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FDA 510(k)

SPIROLITE MODEL MSC-201 SPIROMETER

K-Number: K921513 · 1993-01-27

ApplicantMedical Systems Corp.
Decision Date1993-01-27
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPIROLITE MODEL MSC-201 SPIROMETER is the device name listed in this FDA 510(k) record. The listed applicant is Medical Systems Corp.. It received FDA 510(k) clearance on 1993-01-27 under 510(k) number K921513. 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 SPIROLITE MODEL MSC-201 SPIROMETER?

SPIROLITE MODEL MSC-201 SPIROMETER is a medical device that received FDA 510(k) clearance on 1993-01-27. The listed applicant is Medical Systems Corp.. The 510(k) number is K921513.

When did SPIROLITE MODEL MSC-201 SPIROMETER receive FDA 510(k) clearance?

SPIROLITE MODEL MSC-201 SPIROMETER received FDA 510(k) clearance on 1993-01-27, under 510(k) number K921513.

Who is the listed applicant for SPIROLITE MODEL MSC-201 SPIROMETER?

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

What is the FDA product code for SPIROLITE MODEL MSC-201 SPIROMETER?

The FDA product code for SPIROLITE MODEL MSC-201 SPIROMETER is BZG.

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Other records listing Medical Systems 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.

K931736M-FLEX 5000 C3PMDK921485LA MONT VIDEO PATIENT MONITORING SYSTEMK904353CARDIOMATIC MODEL MSC-2001K903501RADIANT TEMPERATUR INDICATOR MODEL 25EK902192MODEL MSC SA02-5000 PULSE OXIMETERK902608CARDIOMATIC MODEL MSC-1001

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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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