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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 the device name listed in this FDA 510(k) record. The listed applicant is Ganshorn Medizin Electronic GmbH. It received FDA 510(k) clearance on 2016-10-07 under 510(k) 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. The listed applicant is Ganshorn Medizin Electronic GmbH. The 510(k) number is K160116.

When did SpiroScout receive FDA 510(k) clearance?

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

Who is the listed applicant for SpiroScout?

The FDA 510(k) record lists Ganshorn Medizin Electronic GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SpiroScout?

The FDA product code for SpiroScout is BZG.

Other records listing Ganshorn Medizin Electronic GmbH as applicant

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.

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

Related Devices (Code: BZG)

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.

K251777MESI mTABLET SPIROMesi D.O.O.K241843TD-7301 Spirometer (TD-7301)Gostar Co., Ltd.K231416Air Next (NVD-02)Nuvoair ABK230501Spirobank OxiMir Medical International Research USAK230178EasyOne Sky SpirometerNdd Medizintechnik AGK222525Alveoair Digital SpirometerRoundworks Technologies Private Limited

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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