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FDA 510(k)

MICRO DIARY SPIROMETER

K-Number: K100928 · 2011-03-07

ApplicantViasys Respiratory Care, Inc.
Decision Date2011-03-07
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MICRO DIARY SPIROMETER is the device name listed in this FDA 510(k) record. The listed applicant is Viasys Respiratory Care, Inc.. It received FDA 510(k) clearance on 2011-03-07 under 510(k) number K100928. 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 MICRO DIARY SPIROMETER?

MICRO DIARY SPIROMETER is a medical device that received FDA 510(k) clearance on 2011-03-07. The listed applicant is Viasys Respiratory Care, Inc.. The 510(k) number is K100928.

When did MICRO DIARY SPIROMETER receive FDA 510(k) clearance?

MICRO DIARY SPIROMETER received FDA 510(k) clearance on 2011-03-07, under 510(k) number K100928.

Who is the listed applicant for MICRO DIARY SPIROMETER?

The FDA 510(k) record lists Viasys Respiratory Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICRO DIARY SPIROMETER?

The FDA product code for MICRO DIARY SPIROMETER 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 Viasys Respiratory Care, 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.

K073069MODIFICATION TO AVEA VENTILATORK062093AVEA VENTILATOR

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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