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510(k) K093081

POCKET BVM by Microbvm Systems , Ltd. — Product Code BTM

K093081 is an FDA 510(k) premarket notification submitted by Microbvm Systems , Ltd. for the device "POCKET BVM". The FDA issued a decision of Substantially Equivalent on February 5, 2010. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2010
Date Received
October 1, 2009
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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FDA data resources