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FDA 510(k)

FLOWMATE II PLUS, MODEL #4000

K-Number: K982956 · 1998-11-24

ApplicantSpirometrics Medical Equipment Co.
Decision Date1998-11-24
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FLOWMATE II PLUS, MODEL #4000 is the device name listed in this FDA 510(k) record. The listed applicant is Spirometrics Medical Equipment Co.. It received FDA 510(k) clearance on 1998-11-24 under 510(k) number K982956. 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 FLOWMATE II PLUS, MODEL #4000?

FLOWMATE II PLUS, MODEL #4000 is a medical device that received FDA 510(k) clearance on 1998-11-24. The listed applicant is Spirometrics Medical Equipment Co.. The 510(k) number is K982956.

When did FLOWMATE II PLUS, MODEL #4000 receive FDA 510(k) clearance?

FLOWMATE II PLUS, MODEL #4000 received FDA 510(k) clearance on 1998-11-24, under 510(k) number K982956.

Who is the listed applicant for FLOWMATE II PLUS, MODEL #4000?

The FDA 510(k) record lists Spirometrics Medical Equipment Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLOWMATE II PLUS, MODEL #4000?

The FDA product code for FLOWMATE II PLUS, MODEL #4000 is BZG.

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Other records listing Spirometrics Medical Equipment Co. 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.

K001528PC FLOW +K954759FLOWMATE LTE

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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