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FDA 510(k)

ERGOFILTER SPI ACCESSORY TO SPIROLYSER SPL-50

K-Number: K050424 · 2005-06-23

ApplicantFim Medical
Decision Date2005-06-23
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ERGOFILTER SPI ACCESSORY TO SPIROLYSER SPL-50 is the device name listed in this FDA 510(k) record. The listed applicant is Fim Medical. It received FDA 510(k) clearance on 2005-06-23 under 510(k) number K050424. 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 ERGOFILTER SPI ACCESSORY TO SPIROLYSER SPL-50?

ERGOFILTER SPI ACCESSORY TO SPIROLYSER SPL-50 is a medical device that received FDA 510(k) clearance on 2005-06-23. The listed applicant is Fim Medical. The 510(k) number is K050424.

When did ERGOFILTER SPI ACCESSORY TO SPIROLYSER SPL-50 receive FDA 510(k) clearance?

ERGOFILTER SPI ACCESSORY TO SPIROLYSER SPL-50 received FDA 510(k) clearance on 2005-06-23, under 510(k) number K050424.

Who is the listed applicant for ERGOFILTER SPI ACCESSORY TO SPIROLYSER SPL-50?

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 ERGOFILTER SPI ACCESSORY TO SPIROLYSER SPL-50?

The FDA product code for ERGOFILTER SPI ACCESSORY TO SPIROLYSER SPL-50 is BZG.

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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 COTESTERK010761SPL-50 SPIROLYSER

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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