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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 K203762
Device Name Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector
Applicant
Covidien
6135 Gunbarrel Ave.
Boulder,  CO  80301
Applicant Contact Ashley Johnston
Correspondent
Covidien
6135 Gunbarrel Ave.
Boulder,  CO  80301
Correspondent Contact Ashley Johnston
Regulation Number868.1400
Classification Product Code
CCK  
Date Received12/23/2020
Decision Date 09/17/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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