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FDA 510(k)

FUKUDA DENSHI MODEL SPIROSIFT SP-5000

K-Number: K922428 · 1993-01-15

ApplicantFukuda Denshi USA, Inc.
Decision Date1993-01-15
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FUKUDA DENSHI MODEL SPIROSIFT SP-5000 is the device name listed in this FDA 510(k) record. The listed applicant is Fukuda Denshi USA, Inc.. It received FDA 510(k) clearance on 1993-01-15 under 510(k) number K922428. 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 FUKUDA DENSHI MODEL SPIROSIFT SP-5000?

FUKUDA DENSHI MODEL SPIROSIFT SP-5000 is a medical device that received FDA 510(k) clearance on 1993-01-15. The listed applicant is Fukuda Denshi USA, Inc.. The 510(k) number is K922428.

When did FUKUDA DENSHI MODEL SPIROSIFT SP-5000 receive FDA 510(k) clearance?

FUKUDA DENSHI MODEL SPIROSIFT SP-5000 received FDA 510(k) clearance on 1993-01-15, under 510(k) number K922428.

Who is the listed applicant for FUKUDA DENSHI MODEL SPIROSIFT SP-5000?

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

What is the FDA product code for FUKUDA DENSHI MODEL SPIROSIFT SP-5000?

The FDA product code for FUKUDA DENSHI MODEL SPIROSIFT SP-5000 is BZG.

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Other records listing Fukuda Denshi USA, Inc. as applicant

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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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