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FDA 510(k)

SPIROPALM

K-Number: K093174 · 2010-02-26

ApplicantCosmed Srl
Decision Date2010-02-26
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPIROPALM is the device name listed in this FDA 510(k) record. The listed applicant is Cosmed Srl. It received FDA 510(k) clearance on 2010-02-26 under 510(k) number K093174. 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 SPIROPALM?

SPIROPALM is a medical device that received FDA 510(k) clearance on 2010-02-26. The listed applicant is Cosmed Srl. The 510(k) number is K093174.

When did SPIROPALM receive FDA 510(k) clearance?

SPIROPALM received FDA 510(k) clearance on 2010-02-26, under 510(k) number K093174.

Who is the listed applicant for SPIROPALM?

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

What is the FDA product code for SPIROPALM?

The FDA product code for SPIROPALM is BZG.

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Other records listing Cosmed Srl 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.

K190800Cosmed Q-NRG / Q-NRG+ Portable Metabolic MonitorsK162515COSMED K5 Wearable Metabolic TechnologyK120146QUARK SERIESK071533FITMATE SERIESK040549COSMED PONY FXK020745COSMED MICROQUARK

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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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