Safety Information

U.S. Food and Drug Administration
Center for Devices and Radiological Health
Document Mail Center - WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
This message is to acknowledge receipt of your Initial Product Report , which was filed pursuant to the regulations for the
administration and enforcement of the Radiation Control for Health and Safety Act of 1968 (Title 21, Code of Federal Regulations,
Subchapter J) as they pertain to the submission information description below. If your submission is a report, it has been filed
according to reporting requirements in Title 21, Code of Federal Regulations (CFR), Part 1002. Your submission has been assigned an
informal subject title below after “Purpose:”. Your submission has been assigned an ACCESSION NUMBER which can be used by you
and FDA to identify your submission.
WARNING:
THE ACCESSION NUMBER ASSIGNED TO YOUR SUBMISSION DOES NOT IMPLY, CONVEY OR CONSTITUTE FDA APPROVAL OF ANY
REPORT, APPLICATION FOR VARIANCE OR EXEMPTION, NOTIFICATION, OR ANY OTHER SUBMISSION OR ITS CONTENTS. THE
ACCESSION NUMBER IS ONLY AN ACKNOWLEDGMENT THAT FDA HAS RECEIVED YOUR SUBMISSION. IT MAY BE REVOKED BY FDA.
ITS DISCLOSURE IS YOUR RESPONSIBILITY. IT IDENTIFIES YOUR SUBMISSION FOR PRODUCTS OR PRODUCT FAMILIES IDENTIFIED IN
THIS MESSAGE.
Be advised that failure to comply with FDA regulations may result in notification of affected persons and corrective actions at no cost
to the purchaser, pursuant to 21 CFR Part 1003 -- Discovery of Defect or Failure to Comply and 21 CFR Part 1004 -- Repurchase, Repairs,
or Replacement of Electronic Products.
Please be aware that the following CDRH Product Code(s) have been assigned to the product(s) described in this report:
REU defined as Laser Aiming Product, Visible
If these products will be shipped to the United States, the shipping broker will need to provide the full FDA Product Code at the time of
entry, structured as follows:
95R- -EU
- - - - - - - - - - DOCUMENT RECEIVED, FILED, & ACKNOWLEDGED - - - - - - - - - -
This automated notification from the CeSub Submission Process contains general information about the aforementioned submission:
Accession Number: 1910812-000
Date Loaded: Jul 25, 2019
Document Date: Jul 19, 2019
Establishment Name: SHENZHEN JUMAOYUAN SCIENCE AND TECHNOLOGY CO., LTD
Purpose: This submission is a(n) Initial Product Report. These Surveying, Leveling, Alignment Laser Products include
designated model family INFRARED THERMOMETER with model(s) GM1651, GM1850, GM2200, GM550F, GM8905, GM300E,
GM550, GM550E, GM500, GM700, GM900, GM270, GM320/GS320, GM321, GM530, GM531, GM300, WT323A, T323B, WT323C,
WT323D, WT323E, WT533A, WT2200, GM333, GM333A, GM533, GM533A, GT750, GT950, WT320, WT300, WT550, WT700,
WT900, WT1200, WT1500, GM1150, GM1150A, GM1250, GM1350, GM1500, GM1650, WT3651, WT3652, WT3653, WT3655,
WT327A, WT327B.
Submitter: David Jia
Email: [e-mail]
Reporting Official: Kuijun Liu
Email: [e-mail]
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Please note that your firm is required to submit an Annual Report to CDRH every year by September 1.
If you meet all other applicable FDA requirements, you may market the product(s) reported. Please be aware that additional electronic
product radiation control or medical device regulations may apply to your product, such as:
21 CFR 1002.11, requiring report supplements under certain circumstances following the same reporting forms as used for
product reports on your products
21 CFR 1002.13, requiring annual reports to be submitted each year by September 1 using the appropriate reporting form
for annual reports
21 CFR 1010 - 1050, requiring certification to FDA radiation safety performance standards
21 CFR 807, requiring manufacturer registration and device listing, and
21 CFR 807, 812 and 814, requiring medical device clearance or approval
For further information see:
Radiological Health web site - http://www.fda.gov/Radiation-EmittingProducts/default.htm
FDA Electronic Submissions Gateway website -
http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm
If you have any questions, please contact the Director of the Division of Radiological Health, or the branch chief of your respective
product area, as listed on the CDRH Management Directory, under the Office of In Vitro Diagnostics and Radiological Health, Division
of Radiological Health.
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHOffices/ucm127854.htm
Please include a primary (and optional secondary) contact email address in all submissions (and/or cover letters) to facilitate electronic
correspondence.
Sincerely yours,
Division of Radiological Health
Office of In Vitro Diagnostics and Radiological Health
Center for Devices and Radiological Health