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FDA 510(k)

SPL-50 SPIROLYSER

K-Number: K010761 · 2002-03-05

ApplicantFim Medical
Decision Date2002-03-05
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPL-50 SPIROLYSER is the device name listed in this FDA 510(k) record. The listed applicant is Fim Medical. It received FDA 510(k) clearance on 2002-03-05 under 510(k) number K010761. 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 SPL-50 SPIROLYSER?

SPL-50 SPIROLYSER is a medical device that received FDA 510(k) clearance on 2002-03-05. The listed applicant is Fim Medical. The 510(k) number is K010761.

When did SPL-50 SPIROLYSER receive FDA 510(k) clearance?

SPL-50 SPIROLYSER received FDA 510(k) clearance on 2002-03-05, under 510(k) number K010761.

Who is the listed applicant for SPL-50 SPIROLYSER?

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

What is the FDA product code for SPL-50 SPIROLYSER?

The FDA product code for SPL-50 SPIROLYSER is BZG.

Related Clinical Trials

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.

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Other records listing Fim Medical 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.

K161676Q13 SPIROLYSER®K080278TABATABA COTESTERK050424ERGOFILTER SPI ACCESSORY TO SPIROLYSER SPL-50

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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