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 K093757
Device Name MD300C1 FINGERTIP PULSE OXIMETER
Applicant
Beijing Choice Electronic Technololgy Co., Ltd.
North Bldg. 3f, #9
Shuangyuan Rd., Badachu Hitech
Shijingshan District, Beijing,  CN 100041
Applicant Contact YAJING LI
Correspondent
Beijing Choice Electronic Technololgy Co., Ltd.
North Bldg. 3f, #9
Shuangyuan Rd., Badachu Hitech
Shijingshan District, Beijing,  CN 100041
Correspondent Contact YAJING LI
Regulation Number870.2700
Classification Product Code
DQA  
Date Received12/07/2009
Decision Date 03/03/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-