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FDA 510(k)

SPIRO-MASTER PC-10 SPIROMETRY SYSTEM

K-Number: K080921 · 2009-01-21

ApplicantChest M.I., Inc.
Decision Date2009-01-21
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPIRO-MASTER PC-10 SPIROMETRY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Chest M.I., Inc.. It received FDA 510(k) clearance on 2009-01-21 under 510(k) number K080921. 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 SPIRO-MASTER PC-10 SPIROMETRY SYSTEM?

SPIRO-MASTER PC-10 SPIROMETRY SYSTEM is a medical device that received FDA 510(k) clearance on 2009-01-21. The listed applicant is Chest M.I., Inc.. The 510(k) number is K080921.

When did SPIRO-MASTER PC-10 SPIROMETRY SYSTEM receive FDA 510(k) clearance?

SPIRO-MASTER PC-10 SPIROMETRY SYSTEM received FDA 510(k) clearance on 2009-01-21, under 510(k) number K080921.

Who is the listed applicant for SPIRO-MASTER PC-10 SPIROMETRY SYSTEM?

The FDA 510(k) record lists Chest M.I., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPIRO-MASTER PC-10 SPIROMETRY SYSTEM?

The FDA product code for SPIRO-MASTER PC-10 SPIROMETRY SYSTEM is BZG.

Related Clinical Trials

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.

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Other records listing Chest M.I., Inc. 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.

K090646CARDIOTECH SPIROMETRY SYSTEM, MODEL GT-105

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

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

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