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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
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