← Back to catalogue

Cosmed

FDA UDI

Class II (US FDA UDI)

by C O S M E D Srl

Identity

Trade Name
COSMED FDA UDI
Generic Name
Cardiopulmonary stress exercise monitoring system FDA UDI
Device Name
The Cosmed K4b2 is a metabolic measurement system that allows telemetry monitoring of cardiorespiratory function during physical activities as well as in sports medicine and rehabilitation. The K4b2 measures, in real conditions, the ventilation, the O2 consumption the CO2 production and the heart rate of the person being monitored. FDA UDI
Model / Reference
K4b2 FDA UDI
Description
The Cosmed K4b2 is a metabolic measurement system that allows telemetry monitoring of cardiorespiratory function during physical activities as well as in sports medicine and rehabilitation. The K4b2 measures, in real conditions, the ventilation, the O2 consumption the CO2 production and the heart rate of the person being monitored. FDA UDI

Identifiers

Primary DI / UDI-DI
18052400180126 FDA UDI
510(k) Number
K963373 FDA UDI
FDA Product Code
BZC FDA UDI
GMDN Term
Cardiopulmonary stress exercise monitoring system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.1880 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Cardiopulmonary stress exercise monitoring system

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

Similar devices

Also classified as Cardiopulmonary stress exercise monitoring system.

Cleared under the same submission

K963373 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
C O S M E D Srl

Sources (1)

  • FDA UDI fde0c004-f8a3-42a2-8b01-0b98eb55847e 35 fields · synced May 30, 2026