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FDA 510(k)

SPIROMETRICS MODEL 2600 MIRO SPIROMETER

K-Number: K901057 · 1990-04-03

ApplicantSpirometrics, Inc.
Decision Date1990-04-03
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPIROMETRICS MODEL 2600 MIRO SPIROMETER is the device name listed in this FDA 510(k) record. The listed applicant is Spirometrics, Inc.. It received FDA 510(k) clearance on 1990-04-03 under 510(k) number K901057. 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 SPIROMETRICS MODEL 2600 MIRO SPIROMETER?

SPIROMETRICS MODEL 2600 MIRO SPIROMETER is a medical device that received FDA 510(k) clearance on 1990-04-03. The listed applicant is Spirometrics, Inc.. The 510(k) number is K901057.

When did SPIROMETRICS MODEL 2600 MIRO SPIROMETER receive FDA 510(k) clearance?

SPIROMETRICS MODEL 2600 MIRO SPIROMETER received FDA 510(k) clearance on 1990-04-03, under 510(k) number K901057.

Who is the listed applicant for SPIROMETRICS MODEL 2600 MIRO SPIROMETER?

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

What is the FDA product code for SPIROMETRICS MODEL 2600 MIRO SPIROMETER?

The FDA product code for SPIROMETRICS MODEL 2600 MIRO SPIROMETER is BZG.

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Other records listing Spirometrics, Inc. 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.

K915059PEAK FLOW MONITORK911358CMD/DLCO DIAGNOSTIC SPIROMETERK900322CO/CMD-1K900673SERIAL FLOWK884464SPIROMETRICS MODEL 2200 SM200 FLOW SENSORK884465SPIROMETRICS MODEL 2141 SPIRO-FILTER(TM)

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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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