• 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 K161560
Device Name Fingertip Pulse Oximeter MD300CN310
Applicant
BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD.
NO.9 SHUANGYUAN ROAD, BADACHU HI-TECH ZONE
SHIJINGSHAN DISTRICT
Beijing,  CN 100041
Applicant Contact LEI CHEN
Correspondent
BEIJING CHOICE ELECTRONIC TECHNOLOGY 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 Received06/06/2016
Decision Date 10/05/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-