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 K101577
Device Name MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIES
Applicant
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
SUITE 5D, NO. 19, LANE 999
ZHONGSHAN NO. 2 ROAD(S)
SHANGHAI,  CN 20030
Applicant Contact Diana Hong
Correspondent
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
SUITE 5D, NO. 19, LANE 999
ZHONGSHAN NO. 2 ROAD(S)
SHANGHAI,  CN 20030
Correspondent Contact Diana Hong
Regulation Number870.2700
Classification Product Code
DQA  
Date Received06/07/2010
Decision Date 12/02/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-