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 thermometer, electronic, clinical
510(k) Number K191570
Device Name Infrared Thermometer Model MD-H30
Applicant
Guangzhou Berrcom Medical Device Co., Ltd.
No.38 Huanzhen Xi Road, Dagang Town, Nansha
Guangzhou,  CN 511470
Applicant Contact Zhigang Du
Correspondent
Shenzhen Joyantech Consulting Co., Ltd
NO. 55 Shizhou middle road, Nanshan District
Shenzhen,  CN 518000
Correspondent Contact Christy Young
Regulation Number880.2910
Classification Product Code
FLL  
Date Received06/13/2019
Decision Date 11/13/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-