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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name analyzer, gas, carbon-dioxide, gaseous-phase
510(k) Number K213518
Device Name CARESCAPE CO2 Microstream parameter
Covidien llc
6135 Gunbarrel Ave
Boulder,  CO  80301
Applicant Contact Inna Reznikov
Covidien llc
6135 Gunbarrel Ave
Boulder,  CO  80301
Correspondent Contact Inna Reznikov
Regulation Number868.1400
Classification Product Code
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