Fetal Heartbeat Monitor Using Ultrasound
Vietnam·Risk Class TBYT Loại B·BT-380·Bistos Co.,ltd·Registered Oct 28, 2024- Analysis ID
- 240002462/PCBB-HCM
- Submission ID
- 000.00.19.H29-241003-0017
- Product Type
- BT-380
- Product Code
- BT-380
- Manufacturer
- Bistos Co.,ltd
- Product Owner
- Bistos Co.,ltd
- Authorized Representative
- CÔNG TY TNHH XUẤT NHẬP KHẨU KDN
- Intended Use
- The BT-380 fetal heart rate monitor, designed to non-invasively monitor the fetal heart rate and uterine activity, can optionally monitor the mother's ECG, blood oxygen saturation (SpO2), and non-invasive blood pressure (NiBp). The BT-380 generates alerts from the fetal heart rate, displays, stores, and records patient data along with the relevant waveforms.
- Registration Date
- Oct 28, 2024
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Access comprehensive regulatory information for Fetal Heartbeat Monitor Using Ultrasound in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại B medical device is registered under number 240002462/PCBB-HCM and manufactured by Bistos Co.,ltd. The authorized representative in Vietnam is CÔNG TY TNHH XUẤT NHẬP KHẨU KDN.
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