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 analyzer, gas, carbon-dioxide, gaseous-phase
510(k) Number K143150
Device Name CO2 monitoring line with and without in-line filter
Applicant
BESMED HEALTH BUSINESS CORP.
NO.5, LANE116, WU-KONG 2ND RD
NEW TAIPEI CITY,  TW TAIWAN
Applicant Contact WINNIE CHUNG
Correspondent
BESMED HEALTH BUSINESS CORP.
NO.5, LANE116, WU-KONG 2ND RD
NEW TAIPEI CITY,  TW TAIWAN
Correspondent Contact PAUL DRYDEN
Regulation Number868.1400
Classification Product Code
CCK  
Date Received11/03/2014
Decision Date 02/05/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-