Identity
- Trade Name
- COSMED FDA UDI
- Generic Name
- Cardiopulmonary stress exercise monitoring system FDA UDI
- Device Name
- This device is intended for use in clinical and research application to measure oxygen uptake. Fitmate Pro is designed for the measurement of Resting Metabolic Rate and maximal oxygen uptake (VO2max) that is used for assessing basic pulmonary function. FDA UDI
- Model / Reference
- Fitmate Pro FDA UDI
- Description
- This device is intended for use in clinical and research application to measure oxygen uptake. Fitmate Pro is designed for the measurement of Resting Metabolic Rate and maximal oxygen uptake (VO2max) that is used for assessing basic pulmonary function. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 18052400180225 FDA UDI
- 510(k) Number
- K071533 FDA UDI
- FDA Product Code
- BZL FDA UDI
- GMDN Term
- Cardiopulmonary stress exercise monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1730 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.
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- Vyaire — Jaeger Medical GmbH · Class II
- MCG Diagnostics — MEDICAL GRAPHICS CORP. · Class II
- Vyaire — Jaeger Medical GmbH · Class II
- Innocor — Innovision ApS · Class II
- Innocor — Innovision ApS · Class II
- Vyaire — Jaeger Medical GmbH · Class II
Cleared under the same submission
K071533 also covers:
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 6be59187-37ca-4e78-b96d-382c6605ff10 35 fields · synced May 30, 2026