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FDA 510(k)

CARDIOTECH SPIROMETRY SYSTEM, MODEL GT-105

K-Number: K090646 · 2009-07-23

ApplicantChest M.I., Inc.
Decision Date2009-07-23
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CARDIOTECH SPIROMETRY SYSTEM, MODEL GT-105 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 2009-07-23 under 510(k) number K090646. 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 CARDIOTECH SPIROMETRY SYSTEM, MODEL GT-105?

CARDIOTECH SPIROMETRY SYSTEM, MODEL GT-105 is a medical device that received FDA 510(k) clearance on 2009-07-23. The listed applicant is Chest M.I., Inc.. The 510(k) number is K090646.

When did CARDIOTECH SPIROMETRY SYSTEM, MODEL GT-105 receive FDA 510(k) clearance?

CARDIOTECH SPIROMETRY SYSTEM, MODEL GT-105 received FDA 510(k) clearance on 2009-07-23, under 510(k) number K090646.

Who is the listed applicant for CARDIOTECH SPIROMETRY SYSTEM, MODEL GT-105?

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 CARDIOTECH SPIROMETRY SYSTEM, MODEL GT-105?

The FDA product code for CARDIOTECH SPIROMETRY SYSTEM, MODEL GT-105 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.

K080921SPIRO-MASTER PC-10 SPIROMETRY SYSTEM

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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