Cosmed

FDA UDI

Class II (US FDA UDI)

by C O S M E D Srl

Identity

Trade Name: COSMED FDA UDI
Generic Name: Diagnostic spirometer, professional FDA UDI
Device Name: The COSMED Pony FX pulmonary function testing system is a standalone and modular laboratory device for performing the basic lung function tests (Basic Spirometry: Forced Vital Capacity, Slow Vital Capacity, Maximum Voluntary Ventilation) and pulse oximetry. FDA UDI
Model / Reference: Pony FX MIP/MEP FDA UDI
Description: The COSMED Pony FX pulmonary function testing system is a standalone and modular laboratory device for performing the basic lung function tests (Basic Spirometry: Forced Vital Capacity, Slow Vital Capacity, Maximum Voluntary Ventilation) and pulse oximetry. FDA UDI

Identifiers

Primary DI / UDI-DI: 18052400180379 FDA UDI
510(k) Number: K040549 FDA UDI
FDA Product Code: DQA FDA UDI
BTY FDA UDI
GMDN Term: Diagnostic spirometer, professional FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2700 FDA UDI
868.1890 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Diagnostic spirometer, professional

Cosmed by C O S M E D Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Vyaire — Jaeger Medical GmbH · Class II
SPIROVIT SP-250 — Schiller Corp. · Class II
Alpha — Vitalograph Ireland, Ltd. · Class II

Cleared under the same submission

K040549 also covers:

COSMED — C O S M E D SRL
COSMED — C O S M E D SRL

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: C O S M E D Srl

Sources (1)

FDA UDI a88319a8-fb92-44a7-b21b-8edd0d75f3a6 35 fields · synced May 30, 2026