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 K152690
Device Name DISPOSABLE THERMOMETER PROBE SHEATHS
Applicant
Pinghu Sama Medical Packing Co., Ltd.
1 Qunfeng Rd.
South Of Lindai
Pinghu,  CN 314202
Applicant Contact MA JIANZHONG
Correspondent
Beijing Believe Tech.Service Co., Ltd.
1-202, Build 3, Beijing New World
#5 Chaogyang Rd., Chaogyang District
Beijing,  CN 100024
Correspondent Contact RAY WANG
Regulation Number880.2910
Classification Product Code
FLL  
Date Received09/21/2015
Decision Date 01/15/2016
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
Predetermined Change
Control Plan Authorized		 No
-
-