Duns Number:628476459
Device Description: The BPro® BT Ambulatory Blood Pressure Monitoring system is a noninvasive ambulatoryblood The BPro® BT Ambulatory Blood Pressure Monitoring system is a noninvasive ambulatoryblood pressure monitoring system based on arterial tonometry at the radial artery of the wrist with radial pulse waveform acquisition.
Catalog Number
-
Brand Name
BPro BT Ambulatory Blood Pressure Monitoring System
Version/Model Number
T6200 series
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K173028
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
95ba5ad2-5e35-4f77-87b4-746bbc78d75f
Public Version Date
April 07, 2021
Public Version Number
3
DI Record Publish Date
August 14, 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. | 11 |