Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Continuous Measurement Thermometer
510(k) Number K130231
Device Name NON-CONTACT INFRARED THERMOMETER
Applicant
Jinxinbao Electronic Co.,Ltd
Rm. 404, Bldg. 7, Jinhuichang Homeland
Liuhongqiao Rd.
Wenzhou, Zhejiang,  CN 325000
Applicant Contact HELEN NAN
Correspondent
Jinxinbao Electronic Co.,Ltd
Rm. 404, Bldg. 7, Jinhuichang Homeland
Liuhongqiao Rd.
Wenzhou, Zhejiang,  CN 325000
Correspondent Contact HELEN NAN
Regulation Number880.2910
Classification Product Code
FLL  
Date Received01/29/2013
Decision Date 10/15/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-