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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 K201590
Device Name EMMA Capnograph
Applicant
Masimo Corporation
52 Discovery
Irvine,  CA  92618
Applicant Contact Katelynn Kirby
Correspondent
Masimo Corporation
52 Discovery
Irvine,  CA  92618
Correspondent Contact Katelynn Kirby
Regulation Number868.1400
Classification Product Code
CCK  
Date Received06/12/2020
Decision Date 03/29/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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