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FDA 510(k)

SpiroScout

K-Number: K160116 · 2016-10-07

ApplicantGanshorn Medizin Electronic GmbH
Decision Date2016-10-07
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SpiroScout is a medical device manufactured by Ganshorn Medizin Electronic GmbH. It received FDA 510(k) clearance on 2016-10-07 under approval number K160116. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SpiroScout?

SpiroScout is a medical device that received FDA 510(k) clearance on 2016-10-07. It is manufactured by Ganshorn Medizin Electronic GmbH. The 510(k) number is K160116.

When was SpiroScout approved by the FDA?

SpiroScout received FDA 510(k) clearance on 2016-10-07, under approval number K160116.

What company makes SpiroScout?

SpiroScout is manufactured by Ganshorn Medizin Electronic GmbH.

What is the FDA product code for SpiroScout?

The FDA product code for SpiroScout is BZG.

Other Devices by Ganshorn Medizin Electronic GmbH

K240706PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+)

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Official Source

View on FDA Database →

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

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