FDA 510(k)

Q13 SPIROLYSER®

K-Number: K161676 · 2016-10-20

Decision Date2016-10-20

Product CodeBZG

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Q13 SPIROLYSER® is the device name listed in this FDA 510(k) record. The listed applicant is Fim Medical. It received FDA 510(k) clearance on 2016-10-20 under 510(k) number K161676. 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 Q13 SPIROLYSER®?

Q13 SPIROLYSER® is a medical device that received FDA 510(k) clearance on 2016-10-20. The listed applicant is Fim Medical. The 510(k) number is K161676.

When did Q13 SPIROLYSER® receive FDA 510(k) clearance?

Q13 SPIROLYSER® received FDA 510(k) clearance on 2016-10-20, under 510(k) number K161676.

Who is the listed applicant for Q13 SPIROLYSER®?

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

What is the FDA product code for Q13 SPIROLYSER®?

The FDA product code for Q13 SPIROLYSER® is BZG.

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 AB K230501Spirobank OxiMir Medical International Research USA K230178EasyOne Sky SpirometerNdd Medizintechnik AG K222525Alveoair Digital SpirometerRoundworks Technologies Private Limited

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.