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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 K213767
Device Name Endure ETCO2/02 Nasal Cannula
Applicant
Endure Industries, Inc.
45 N Fulton St.
Homer,  NY  13077
Applicant Contact Manoj Kumar
Correspondent
Endure Industries, Inc.
45 N Fulton St.
Homer,  NY  13077
Correspondent Contact Manoj Kumar
Regulation Number868.1400
Classification Product Code
CCK  
Subsequent Product Code
CAT  
Date Received12/01/2021
Decision Date 09/12/2023
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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