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510(k) K172388

VPOD ITPR by Advanced Circulatory System, A Wholly Owned Subsidiary OF — Product Code BWF

K172388 is an FDA 510(k) premarket notification submitted by Advanced Circulatory System, A Wholly Owned Subsidiary OF for the device "VPOD ITPR". The FDA issued a decision of Substantially Equivalent on December 22, 2017. The device falls under product code BWF (Spirometer, Therapeutic (Incentive)), a Class II device regulated under 21 CFR 868.5690.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2017
Date Received
August 8, 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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FDA data resources