MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM— 510(k) K160837

Name: FDA 510(k) clearance K160837
Creator: U.S. Food and Drug Administration
Published: 2017-02-23

Substantially Equivalent

Medinet Srl

FDA 510(k) clearance K160837 for MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM, Substantially Equivalent on 2017-02-23. Applicant: Medinet Srl. Device class: 2.

Clearance details

Applicant: Medinet Srl
Product code: Code BWF
Device class: Class 2
Regulation: 21 CFR 868.5690
Advisory panel: Anesthesiology
Date received: 2016-03-25
Decision date: 2017-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milano, IT

Download summary PDF View on FDA.gov ↗

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