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510(k) K160837

MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM by Medinet Srl — Product Code BWF

K160837 is an FDA 510(k) premarket notification submitted by Medinet Srl for the device "MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM". The FDA issued a decision of Substantially Equivalent on February 23, 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
February 23, 2017
Date Received
March 25, 2016
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