FDA 510(k)

MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM

Número K: K160837 · 2017-02-23

Data da decisão2017-02-23

Código do produtoBWF

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM is the device name listed in this FDA 510(k) record. The listed applicant is Medinet Srl. It received FDA 510(k) clearance on 2017-02-23 under 510(k) number K160837. The device is classified under product code BWF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM?

MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM is a medical device that received FDA 510(k) clearance on 2017-02-23. The listed applicant is Medinet Srl. The 510(k) number is K160837.

When did MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM receive FDA 510(k) clearance?

MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM received FDA 510(k) clearance on 2017-02-23, under 510(k) number K160837.

Who is the listed applicant for MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM?

The FDA 510(k) record lists Medinet Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM?

The FDA product code for MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM is BWF.

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