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 K081125
Device Name WRIST PULSE OXIMETER MD300W
Applicant
Beijing Choice Electronic Technololgy Co., Ltd.
Rm. 1127-1128 Bldg. B
Bailangyuan Fuxing Rd. #A36
Beijing,  CN 100041
Applicant Contact LEI WANG
Correspondent
Beijing Choice Electronic Technololgy Co., Ltd.
Rm. 1127-1128 Bldg. B
Bailangyuan Fuxing Rd. #A36
Beijing,  CN 100041
Correspondent Contact LEI WANG
Regulation Number870.2700
Classification Product Code
DQA  
Date Received04/21/2008
Decision Date 07/02/2008
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
-
-