Duns Number:689908411
Device Description: Bistos’ BT-200T is a pocket size Fetal Doppler that measures the fetal heart rate and out Bistos’ BT-200T is a pocket size Fetal Doppler that measures the fetal heart rate and out put the fetal sound through built-in speaker. By measuring fetal heart rate (FHR), they are able to predict fetal well-being.
Catalog Number
MKT-200-1501
Brand Name
N/A
Version/Model Number
BT-200T
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
K100885,K100885,K100885,K100885,K100885
Product Code
HGM
Product Code Name
System, Monitoring, Perinatal
Public Device Record Key
56e0d085-c047-4001-83b5-9e8fa0a57b4e
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
June 14, 2016
Package DI Number
30887529000046
Quantity per Package
20
Contains DI Package
10887529000042
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |