Duns Number:438896136
Device Description: The Cosmed K4b2 is a metabolic measurement system that allows telemetry monitoring of card 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.
Catalog Number
-
Brand Name
COSMED
Version/Model Number
K4b2
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K963373
Product Code
BZC
Product Code Name
Calculator, Pulmonary Function Data
Public Device Record Key
fde0c004-f8a3-42a2-8b01-0b98eb55847e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |