Duns Number:808473453
Device Description: APDM’s Access Point is an accessory that enables wireless streaming to a computer for the APDM’s Access Point is an accessory that enables wireless streaming to a computer for the Opal V2C.
Catalog Number
APV2C
Brand Name
Access Point 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
a4be2865-c3b2-4b73-bf06-debd3aea8305
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 |