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Cosmed Pony FX

FDA 510(k)

Class II (US FDA 510(k))

510(k) K040549

by COSMED Srl

Identifiers

510(k) Number
K040549 FDA 510(k)
FDA Product Code
BTY FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.1890 FDA 510(k)
Regulation Number
868.1890 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Cosmed Pony FX is a desktop spirometer used for pulmonary function tests. It is an electrical medical device designed to measure and calculate predicted values for pulmonary function assessment.

The device is supplied as a measuring instrument and is intended for use in clinical settings. It is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided. The device has FDA 510(k) clearance with product code BTY and is classified under regulation number 868.1890.

Frequently asked questions

What is the COSMED PONY FX used for?

The COSMED PONY FX is a desktop spirometer designed for pulmonary function tests. It measures and calculates predicted values to assist clinicians in assessing pulmonary function in clinical settings.

Is the COSMED PONY FX a single-use device?

The device is not specified as single-use or reusable in the provided information. It is supplied as a measuring instrument for clinical use, but no details regarding reusability are available.

What regulatory approvals does the COSMED PONY FX have?

The COSMED PONY FX has FDA 510(k) clearance with product code BTY and is classified under regulation number 868.1890. It was determined to be substantially equivalent to predicate devices.

What are the specifications of the COSMED PONY FX?

The COSMED PONY FX is an electrical medical device designed for desktop use. It measures and calculates predicted values for pulmonary function assessment, though specific measurements, dimensions, or technical specifications are not provided in the available data.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: COSMED PONY FX USER MANUAL Pdf Download | ManualsLib, Cosmed Pony FX Manuals | ManualsLib, PDF Cosmed Pony FX User manual.pdf - iFixit, COSMED - The Metabolic Company, COSMED Pony FX Manual: AI Chat & PDF Download | Manualzz

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
COSMED Srl

Sources (1)

  • FDA 510(k) K040549 24 fields · synced Sep 21, 2026