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FDA 510(k)

COSMED QUARK C12/QUARK T12

K-Number: K014262 · 2002-03-26

ApplicantCosmed Srl
Decision Date2002-03-26
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COSMED QUARK C12/QUARK T12 is the device name listed in this FDA 510(k) record. The listed applicant is Cosmed Srl. It received FDA 510(k) clearance on 2002-03-26 under 510(k) number K014262. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COSMED QUARK C12/QUARK T12?

COSMED QUARK C12/QUARK T12 is a medical device that received FDA 510(k) clearance on 2002-03-26. The listed applicant is Cosmed Srl. The 510(k) number is K014262.

When did COSMED QUARK C12/QUARK T12 receive FDA 510(k) clearance?

COSMED QUARK C12/QUARK T12 received FDA 510(k) clearance on 2002-03-26, under 510(k) number K014262.

Who is the listed applicant for COSMED QUARK C12/QUARK T12?

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 C12/QUARK T12?

The FDA product code for COSMED QUARK C12/QUARK T12 is DPS.

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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: DPS)

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.

K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France Commercial

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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