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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Emergency, Manual (Resuscitator)
510(k) Number K221841
Device Name EOlife®
Applicant
Archeon
2 Chemin Des Aiguillettes
Besançon,  FR 25000
Applicant Contact Valentine OQDA
Correspondent
Gloster Biomedical International, LLC
577 N. Hope Ave.
Santa Barbara,  CA  93110
Correspondent Contact Catherine Gloster
Regulation Number868.5915
Classification Product Code
BTM  
Date Received06/24/2022
Decision Date 03/18/2023
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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