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510(k) K051964

POWERNEB by Comedica , Inc. — Product Code NHJ

K051964 is an FDA 510(k) premarket notification submitted by Comedica , Inc. for the device "POWERNEB". The FDA issued a decision of Substantially Equivalent on December 1, 2005. The device falls under product code NHJ (Device, Positive Pressure Breathing, Intermittent), a Class II device regulated under 21 CFR 868.5905.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 2005
Date Received
July 20, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Positive Pressure Breathing, Intermittent
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type

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FDA data resources