Duns Number:029578633
Device Description: The FD-300P is a ultrasonic Doppler that allows expectant mothers and health care professi The FD-300P is a ultrasonic Doppler that allows expectant mothers and health care professionals to retrieve and listen to the fetal heart rate.
Catalog Number
-
Brand Name
FaceLake
Version/Model Number
FD-300P
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K082480
Product Code
KNG
Product Code Name
Monitor, Ultrasonic, Fetal
Public Device Record Key
4bef9341-c3f0-4af4-9ab4-9c9947bf53b3
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
March 21, 2018
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. | 16 |