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FDA 510(k)

COSMED QUARK

K-Number: K001174 · 2001-01-11

ApplicantCosmed Srl
Decision Date2001-01-11
Product CodeBZC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

COSMED QUARK is the device name listed in this FDA 510(k) record. The listed applicant is Cosmed Srl. It received FDA 510(k) clearance on 2001-01-11 under 510(k) number K001174. The device is classified under product code BZC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COSMED QUARK?

COSMED QUARK is a medical device that received FDA 510(k) clearance on 2001-01-11. The listed applicant is Cosmed Srl. The 510(k) number is K001174.

When did COSMED QUARK receive FDA 510(k) clearance?

COSMED QUARK received FDA 510(k) clearance on 2001-01-11, under 510(k) number K001174.

Who is the listed applicant for COSMED QUARK?

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 COSMED QUARK?

The FDA product code for COSMED QUARK is BZC.

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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 SERIESK093174SPIROPALMK071533FITMATE SERIESK040549COSMED PONY FX

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Related Devices (Code: BZC)

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.

K240293STSTechbopulm, Ltd.K183567Vyntus/SentrySuite Product LineVyaire MedicalK190853Vyntus BODYVyaire Medical, Inc.K181524Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CARTVyaire Medical, Inc.K162515COSMED K5 Wearable Metabolic TechnologyCosmed SrlK161295MiniBox +Pulmone Advanced Medical Devices, Ltd.

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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