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510(k) K251086

PnueAira (PNCU-01) by Biotab, LLC — Product Code JOW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2025
Date Received
April 9, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Sleeve, Limb, Compressible
Device Class
Class II
Regulation Number
870.5800
Review Panel
CV
Submission Type

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