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FDA 510(k)

PRESTO DIAGNOSTIC SPIROMETER

K-Number: K894997 · 1989-10-30

ApplicantTamarac Systems Corp.
Decision Date1989-10-30
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PRESTO DIAGNOSTIC SPIROMETER is the device name listed in this FDA 510(k) record. The listed applicant is Tamarac Systems Corp.. It received FDA 510(k) clearance on 1989-10-30 under 510(k) number K894997. 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 PRESTO DIAGNOSTIC SPIROMETER?

PRESTO DIAGNOSTIC SPIROMETER is a medical device that received FDA 510(k) clearance on 1989-10-30. The listed applicant is Tamarac Systems Corp.. The 510(k) number is K894997.

When did PRESTO DIAGNOSTIC SPIROMETER receive FDA 510(k) clearance?

PRESTO DIAGNOSTIC SPIROMETER received FDA 510(k) clearance on 1989-10-30, under 510(k) number K894997.

Who is the listed applicant for PRESTO DIAGNOSTIC SPIROMETER?

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

What is the FDA product code for PRESTO DIAGNOSTIC SPIROMETER?

The FDA product code for PRESTO DIAGNOSTIC SPIROMETER is BZG.

Related Clinical Trials

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Other records listing Tamarac 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.

K940836PEAKLOG AND DISPLAY SOFTWAREK894680RS232 FLOW SENSOR AND SOFTWARE PACKAGE

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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