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510(k) K173918

VersaPAP Positive Airway Pressure (PAP) Device by Trudell Medical International — Product Code BWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2018
Date Received
December 22, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Therapeutic (Incentive)
Device Class
Class II
Regulation Number
868.5690
Review Panel
AN
Submission Type

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