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FDA 510(k)

PORTA-SCREEN SPIROMETER

K-Number: K951367 · 1995-04-14

ApplicantS & M Instrument Co.
Decision Date1995-04-14
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PORTA-SCREEN SPIROMETER is the device name listed in this FDA 510(k) record. The listed applicant is S & M Instrument Co.. It received FDA 510(k) clearance on 1995-04-14 under 510(k) number K951367. 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 PORTA-SCREEN SPIROMETER?

PORTA-SCREEN SPIROMETER is a medical device that received FDA 510(k) clearance on 1995-04-14. The listed applicant is S & M Instrument Co.. The 510(k) number is K951367.

When did PORTA-SCREEN SPIROMETER receive FDA 510(k) clearance?

PORTA-SCREEN SPIROMETER received FDA 510(k) clearance on 1995-04-14, under 510(k) number K951367.

Who is the listed applicant for PORTA-SCREEN SPIROMETER?

The FDA 510(k) record lists S & M Instrument Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PORTA-SCREEN SPIROMETER?

The FDA product code for PORTA-SCREEN SPIROMETER is BZG.

Related Clinical Trials

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Other records listing S & M Instrument 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.

K943146PORTA-RESP MONITORK920877THE KEYSTONE SYSTEMK884051DSM-1 DOSIMETER

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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