Duns Number:071829634
Device Description: An electrically-powered remote used to wirelessly receive and transmit physiologic data su An electrically-powered remote used to wirelessly receive and transmit physiologic data such as blood pressures to a connected computer with dedicated physiologic software. The software stores the data transmitted by the physiologic device.
Catalog Number
01531
Brand Name
Hokanson
Version/Model Number
TD312 RF Receiver
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
K842067
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
271725e9-f178-491d-9225-8872fbecb7cf
Public Version Date
November 10, 2021
Public Version Number
6
DI Record Publish Date
September 22, 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. | 218 |