Duns Number:260233256
Device Description: Complete ToFscan Kit with robust demonstration case for ToFscan and its accessories (TOF-M Complete ToFscan Kit with robust demonstration case for ToFscan and its accessories (TOF-MU, TOF-CHAR_US AC power/charger, clamp, TOF-S2_B sensor, cable support, user manual)
Catalog Number
TOF-DEMO
Brand Name
TOF-DEMO
Version/Model Number
TOF-DEMO
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K172690
Product Code
KOI
Product Code Name
Stimulator, Nerve, Peripheral, Electric
Public Device Record Key
2353b1f8-7c23-497d-9fb2-934054317ea2
Public Version Date
June 21, 2022
Public Version Number
1
DI Record Publish Date
June 10, 2022
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |