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 Oximeter
510(k) Number K082641
Device Name FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL
Applicant
Contec Medical System Co., Ltd.
Suite 8d, Zhongxin Zhongshan
Mansion, # 19 Ln. 999
Zhong Shan, Shanghai,  CN 20030
Applicant Contact Diana Hong
Correspondent
Contec Medical System Co., Ltd.
Suite 8d, Zhongxin Zhongshan
Mansion, # 19 Ln. 999
Zhong Shan, Shanghai,  CN 20030
Correspondent Contact Diana Hong
Regulation Number870.2700
Classification Product Code
DQA  
Date Received09/11/2008
Decision Date 11/10/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-