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510(k) K212905

Sotair Device by Safe Bvm Corporation — Product Code BTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2022
Date Received
September 13, 2021
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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