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FDA 510(k)

SPIROTEQ

K-Number: K894556 · 1990-01-09

ApplicantSystem Analysis Corp.
Decision Date1990-01-09
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPIROTEQ is the device name listed in this FDA 510(k) record. The listed applicant is System Analysis Corp.. It received FDA 510(k) clearance on 1990-01-09 under 510(k) number K894556. 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 SPIROTEQ?

SPIROTEQ is a medical device that received FDA 510(k) clearance on 1990-01-09. The listed applicant is System Analysis Corp.. The 510(k) number is K894556.

When did SPIROTEQ receive FDA 510(k) clearance?

SPIROTEQ received FDA 510(k) clearance on 1990-01-09, under 510(k) number K894556.

Who is the listed applicant for SPIROTEQ?

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

What is the FDA product code for SPIROTEQ?

The FDA product code for SPIROTEQ is BZG.

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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

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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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