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 K141128
Device Name FINGERTIP PULSE OXIMETER
Applicant
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
NO. 9 SHUANGYUAN ROAD, BADACHU HI-TECH ZONE
SHIJINGSHAN DISTRICT
BEIJING,  CN 100041
Applicant Contact LEI CHEN
Correspondent
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
NO. 9 SHUANGYUAN ROAD, BADACHU HI-TECH ZONE
SHIJINGSHAN DISTRICT
BEIJING,  CN 100041
Correspondent Contact LEI CHEN
Regulation Number870.2700
Classification Product Code
DQA  
Date Received05/01/2014
Decision Date 08/13/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-