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FDA 510(k)

SPIROTEL

K-Number: K043528 · 2005-07-19

ApplicantMir Medical Intl. Research Srl
Decision Date2005-07-19
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPIROTEL 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 2005-07-19 under 510(k) number K043528. 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 SPIROTEL?

SPIROTEL is a medical device that received FDA 510(k) clearance on 2005-07-19. The listed applicant is Mir Medical Intl. Research Srl. The 510(k) number is K043528.

When did SPIROTEL receive FDA 510(k) clearance?

SPIROTEL received FDA 510(k) clearance on 2005-07-19, under 510(k) number K043528.

Who is the listed applicant for SPIROTEL?

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 SPIROTEL?

The FDA product code for SPIROTEL 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.

K130784SPIROTELK122384MINISPIRK081033MIROXIK082766MODIFICATION TO MINISPIR, SPIROLAB IIIK072979SPIROBANK GK061875MINISPIR; SPIROLAB III

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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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