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FDA 510(k)

MULTISPIRO SA/100

K-Number: K863134 · 1986-12-15

ApplicantBiotrine Corp.
Decision Date1986-12-15
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MULTISPIRO SA/100 is the device name listed in this FDA 510(k) record. The listed applicant is Biotrine Corp.. It received FDA 510(k) clearance on 1986-12-15 under 510(k) number K863134. 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 MULTISPIRO SA/100?

MULTISPIRO SA/100 is a medical device that received FDA 510(k) clearance on 1986-12-15. The listed applicant is Biotrine Corp.. The 510(k) number is K863134.

When did MULTISPIRO SA/100 receive FDA 510(k) clearance?

MULTISPIRO SA/100 received FDA 510(k) clearance on 1986-12-15, under 510(k) number K863134.

Who is the listed applicant for MULTISPIRO SA/100?

The FDA 510(k) record lists Biotrine Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MULTISPIRO SA/100?

The FDA product code for MULTISPIRO SA/100 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 Biotrine 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.

K915060ASTECH HOME PEAK FLOW METERK883704MULTIICHALLENGE NEBULIZER SYSTEMK844226B-1000K813414PEAK FLOW MONITORK812825FLO-COR I

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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