Duns Number:689908411
Device Description: BT-300 is the fetal monitor that measures the fetal heart rate(FHR) which may be evaluated BT-300 is the fetal monitor that measures the fetal heart rate(FHR) which may be evaluated to predict fetal status and uterine contraction. BT-300 irradiates ultrasound wave to the abdomen of a pregnant woman, and detects the Doppler frequency signal reflected from the heart of the fetus.
Catalog Number
OSD-15300-001
Brand Name
N/A
Version/Model Number
BT-300
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
K052190,K052190,K052190
Product Code
HGM
Product Code Name
System, Monitoring, Perinatal
Public Device Record Key
1f30ef95-46bf-402c-9c27-7ebd6a064e1b
Public Version Date
June 05, 2020
Public Version Number
5
DI Record Publish Date
June 14, 2016
Package DI Number
10887529000103
Quantity per Package
1
Contains DI Package
00887529000106
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 |