Duns Number:808473453
Device Description: APDM’s Docking Station is an accessory that transfers the raw sensor data logged to a comp APDM’s Docking Station is an accessory that transfers the raw sensor data logged to a computer for the Opal V2C. Additionally, the Docking Station recharges the battery of an Opal V2C.
Catalog Number
DSV2C
Brand Name
Docking Station V2C
Version/Model Number
V2C
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"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ISD
Product Code Name
Exerciser, Measuring
Public Device Record Key
d05ddd7c-8a84-4553-8e17-a89ccfd96625
Public Version Date
March 05, 2020
Public Version Number
2
DI Record Publish Date
December 30, 2019
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. | 3 |