Duns Number:438896136
Device Description: This device is intended for use in clinical and research application to measure oxygen upt 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.
Catalog Number
-
Brand Name
COSMED
Version/Model Number
Fitmate Pro
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
K071533
Product Code
BZL
Product Code Name
Computer, Oxygen-Uptake
Public Device Record Key
6be59187-37ca-4e78-b96d-382c6605ff10
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 |