Duns Number:043063893
Device Description: The TrueOne® 2400 is a compact, integrated metabolic measurement system for cardiopulmonar The TrueOne® 2400 is a compact, integrated metabolic measurement system for cardiopulmonary stress testing, indirect calorimetry, and maximal O2 consumption measurement.
Catalog Number
-
Brand Name
TrueOne 2400
Version/Model Number
MMS-2400
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K941843
Product Code
BZC
Product Code Name
Calculator, Pulmonary Function Data
Public Device Record Key
44d1a8c9-352a-49b0-9439-7086358b3269
Public Version Date
March 08, 2022
Public Version Number
3
DI Record Publish Date
September 06, 2018
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. | 1 |