Duns Number:421298453
Device Description: Wrist blood pressure monitor: Small, portable, easy to carry, measuring the arterialblood Wrist blood pressure monitor: Small, portable, easy to carry, measuring the arterialblood pressure of wrist at any time and place. Wrist sphygmomanometer isconvenient not to take off the coat, especially in winter
Catalog Number
-
Brand Name
AGE
Version/Model Number
BW-601
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
K151281
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
c4ea6fda-c062-4379-93d0-3c684fd33090
Public Version Date
November 08, 2019
Public Version Number
4
DI Record Publish Date
October 29, 2017
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. | 19 |