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FDA 510(k)

SPIROVISION SV-III PC BASED SPIROMETER KIT MICRO

K-Number: K953948 · 1996-06-25

ApplicantFuturemed America, Inc.
Decision Date1996-06-25
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPIROVISION SV-III PC BASED SPIROMETER KIT MICRO 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 1996-06-25 under 510(k) number K953948. 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 SPIROVISION SV-III PC BASED SPIROMETER KIT MICRO?

SPIROVISION SV-III PC BASED SPIROMETER KIT MICRO is a medical device that received FDA 510(k) clearance on 1996-06-25. The listed applicant is Futuremed America, Inc.. The 510(k) number is K953948.

When did SPIROVISION SV-III PC BASED SPIROMETER KIT MICRO receive FDA 510(k) clearance?

SPIROVISION SV-III PC BASED SPIROMETER KIT MICRO received FDA 510(k) clearance on 1996-06-25, under 510(k) number K953948.

Who is the listed applicant for SPIROVISION SV-III PC BASED SPIROMETER KIT MICRO?

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 SPIROVISION SV-III PC BASED SPIROMETER KIT MICRO?

The FDA product code for SPIROVISION SV-III PC BASED SPIROMETER KIT MICRO 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 SPIROMETERK950223DISCOVERY GRAPHIC PORTABLE SPIROMETER

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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