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510(k) K221841

EOlife® by Archeon — Product Code BTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2023
Date Received
June 24, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Emergency, Manual (Resuscitator)
Device Class
Class II
Regulation Number
868.5915
Review Panel
AN
Submission Type

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