Cosmed
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 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.
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
Record
| Listed by | C O S M E D SRL |
|---|---|
| FDA product code | BZC |
| Device type | Calculator, Pulmonary Function Data |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1880 |
| 510(k) | K162515 |
| Record published | 2017-08-09 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| K5 | In distribution | |
| K4b2 | In distribution | |
| K4b2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Jaeger | Jaeger Medical GmbH | 227 |
| Vyaire | Jaeger Medical GmbH | 120 |
| Vyntus | Jaeger Medical GmbH | 14 |
| Innocor | Innovision Medical Technologies, LLC | 6 |
| Vyntus | Vyaire Medical, Inc. | 3 |
| APS-Pro SA | Jaeger Medical GmbH | 3 |
| MGC Diagnostics | Medical Graphics Corp. | 2 |
| TransAir3 | Medi Soft SA | 1 |
| MasterScreen PFT | Jaeger Medical GmbH | 1 |
| Respiratory Mechanics Sensor → Neonatal | Draeger Medical Systems, Inc. | 1 |
| SentrySuite Software | Jaeger Medical GmbH | 1 |
| TrueOne 2400 | Parvomedics, Incorporated | 1 |
Showing 12 of 19. All products under Calculator, Pulmonary Function Data
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.