Cosmed
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…
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.
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Mehow Innovative Ltd | Shenzhen | Guangdong | Contract manufacturer | 2 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | C O S M E D SRL |
|---|---|
| FDA product code | BZL |
| Device type | Computer, Oxygen-Uptake |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1730 |
| 510(k) | K071533 |
| Record published | 2016-09-23 |
| Record revised | 2022-06-10 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Fitmate GS | In distribution | |
| Fitmate Pro | In distribution | |
| Fitmate Med | In distribution | |
| Fitmate | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MGC Diagnostics | Medical Graphics Corp. | 43 |
| Metaphor Flow Sensor | TreyMed, Inc. | 3 |
| Computer, Oxygen-Uptake | GE Healthcare Finland OY | 2 |
| MCG Diagnostics | Medical Graphics Corp. | 1 |
| Vista Mini-CPX Silver Edition | Vacumed | 1 |
| Maxii | AEI Technologies Inc. | 1 |
| MGC Diganostics | Medical Graphics Corp. | 1 |
| MAXIIa | AEI Technologies Inc. | 1 |
| Vista-MX Metabolic Measurement System | Vacumed | 1 |
| MGC Diagnsotics | Medical Graphics Corp. | 1 |
| MediPines Gas Exchange Monitor Starter Kit | Medipines Corporation | 1 |
| Microlife | Microlife USA, Inc. | 1 |
Showing 12 of 22. All products under Computer, Oxygen-Uptake
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.