Duns Number:628476459
Device Description: The A-PULSE CASPro® is a noninvasive blood pressure monitoring system designed to measure The A-PULSE CASPro® is a noninvasive blood pressure monitoring system designed to measure the Central Aortic Systolic Pressure (CASP) and additional arterial pulse waveform related indices based on arterial tonometry at the radial artery of the wrist.
Catalog Number
-
Brand Name
A-PULSE CASPro® Central Aortic Systolic Pressure Monitoring Device(Professional)
Version/Model Number
T7100 Series
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2020
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K101002
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
61582c46-b437-4627-9555-1e3b0fcb12dc
Public Version Date
October 06, 2022
Public Version Number
6
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. | 11 |