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FDA 510(k)

DISCOVERY GRAPHIC PORTABLE SPIROMETER

K-Number: K950223 · 1995-11-17

ApplicantFuturemed America, Inc.
Decision Date1995-11-17
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DISCOVERY GRAPHIC PORTABLE SPIROMETER is the device name listed in this FDA 510(k) record. The listed applicant is Futuremed America, Inc.. It received FDA 510(k) clearance on 1995-11-17 under 510(k) number K950223. 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 DISCOVERY GRAPHIC PORTABLE SPIROMETER?

DISCOVERY GRAPHIC PORTABLE SPIROMETER is a medical device that received FDA 510(k) clearance on 1995-11-17. The listed applicant is Futuremed America, Inc.. The 510(k) number is K950223.

When did DISCOVERY GRAPHIC PORTABLE SPIROMETER receive FDA 510(k) clearance?

DISCOVERY GRAPHIC PORTABLE SPIROMETER received FDA 510(k) clearance on 1995-11-17, under 510(k) number K950223.

Who is the listed applicant for DISCOVERY GRAPHIC PORTABLE SPIROMETER?

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

What is the FDA product code for DISCOVERY GRAPHIC PORTABLE SPIROMETER?

The FDA product code for DISCOVERY GRAPHIC PORTABLE 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 Futuremed America, 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.

K973456SPIROBANK PORTABLE PC BASED SPIROMETERK953948SPIROVISION SV-III PC BASED SPIROMETER KIT MICRO

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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