Duns Number:069261402
Device Description: 8 MHz CW Doppler probe for the Smartdop XT.
Catalog Number
BT8M05S8AXT
Brand Name
BT8M05S8AXT
Version/Model Number
BT8M05S8AXT
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 02, 2018
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K934638
Product Code
JOP
Product Code Name
Transducer, Ultrasonic
Public Device Record Key
daa6bfde-adc1-426a-9479-69e39eb55938
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 17, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 86 |