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FDA 510(k)

MODIFICATION TO MINISPIR, SPIROLAB III

K-Number: K082766 · 2008-12-17

ApplicantMir Medical Intl. Research Srl
Decision Date2008-12-17
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO MINISPIR, SPIROLAB III is the device name listed in this FDA 510(k) record. The listed applicant is Mir Medical Intl. Research Srl. It received FDA 510(k) clearance on 2008-12-17 under 510(k) number K082766. 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 MODIFICATION TO MINISPIR, SPIROLAB III?

MODIFICATION TO MINISPIR, SPIROLAB III is a medical device that received FDA 510(k) clearance on 2008-12-17. The listed applicant is Mir Medical Intl. Research Srl. The 510(k) number is K082766.

When did MODIFICATION TO MINISPIR, SPIROLAB III receive FDA 510(k) clearance?

MODIFICATION TO MINISPIR, SPIROLAB III received FDA 510(k) clearance on 2008-12-17, under 510(k) number K082766.

Who is the listed applicant for MODIFICATION TO MINISPIR, SPIROLAB III?

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

What is the FDA product code for MODIFICATION TO MINISPIR, SPIROLAB III?

The FDA product code for MODIFICATION TO MINISPIR, SPIROLAB III is BZG.

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Other records listing Mir Medical Intl. Research Srl 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.

K130784SPIROTELK122384MINISPIRK081033MIROXIK072979SPIROBANK GK061875MINISPIR; SPIROLAB IIIK061712SPIROBANK II

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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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