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FDA 510(k)

COSMED PONY FX

K-Number: K040549 · 2004-09-28

ApplicantCosmed Srl
Decision Date2004-09-28
Product CodeBTY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

COSMED PONY FX is the device name listed in this FDA 510(k) record. The listed applicant is Cosmed Srl. It received FDA 510(k) clearance on 2004-09-28 under 510(k) number K040549. The device is classified under product code BTY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COSMED PONY FX?

COSMED PONY FX is a medical device that received FDA 510(k) clearance on 2004-09-28. The listed applicant is Cosmed Srl. The 510(k) number is K040549.

When did COSMED PONY FX receive FDA 510(k) clearance?

COSMED PONY FX received FDA 510(k) clearance on 2004-09-28, under 510(k) number K040549.

Who is the listed applicant for COSMED PONY FX?

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 PONY FX?

The FDA product code for COSMED PONY FX is BTY.

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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 SERIESK020745COSMED MICROQUARK

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Related Devices (Code: BTY)

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.

K260242CPETWise PlatformMedibyt , Ltd.K242809Ascent Cardiorespiratory Diagnostic SoftwareMedical Graphics CorporationK223629SpiroSphere, SpiroSphereECG, CardioSphereEresearchtechnology GmbHK231561Pulmonary Function Tester, Model: A9Guangzhou Homesun Medical Technology Co., Ltd.K222982Virtus Metabolic MonitorVirtus Technology ApsK221030Model 9100 PFT/DICOVitalograph Ireland, 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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