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 K213518
Device Name CARESCAPE CO2 Microstream parameter
Applicant
Covidien llc
6135 Gunbarrel Ave
Boulder,  CO  80301
Applicant Contact Inna Reznikov
Correspondent
Covidien llc
6135 Gunbarrel Ave
Boulder,  CO  80301
Correspondent Contact Inna Reznikov
Regulation Number868.1400
Classification Product Code
CCK  
Date Received11/03/2021
Decision Date 04/12/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-