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FDA 510(k)

MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM

K-Number: K160837 · 2017-02-23

ApplicantMedinet Srl
Decision Date2017-02-23
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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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Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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