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FDA 510(k)

SPIROMATE AS-500

K-Number: K842372 · 1984-06-26

ApplicantRiko Medical & Scientific Instrument Corp.
Decision Date1984-06-26
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPIROMATE AS-500 is the device name listed in this FDA 510(k) record. The listed applicant is Riko Medical & Scientific Instrument Corp.. It received FDA 510(k) clearance on 1984-06-26 under 510(k) number K842372. 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 SPIROMATE AS-500?

SPIROMATE AS-500 is a medical device that received FDA 510(k) clearance on 1984-06-26. The listed applicant is Riko Medical & Scientific Instrument Corp.. The 510(k) number is K842372.

When did SPIROMATE AS-500 receive FDA 510(k) clearance?

SPIROMATE AS-500 received FDA 510(k) clearance on 1984-06-26, under 510(k) number K842372.

Who is the listed applicant for SPIROMATE AS-500?

The FDA 510(k) record lists Riko Medical & Scientific Instrument Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPIROMATE AS-500?

The FDA product code for SPIROMATE AS-500 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 Riko Medical & Scientific Instrument Corp. 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.

K862023SPIROMATE AS-600K853922PLOTTER FOR AS-500

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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