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FDA 510(k), K173028, BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software
FDA 510(k), K173028, BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software
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510(K) Number: K173028
Device Name: BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software
Manufacturer: Ngak Hwee Chua
Device Classification Name: System, Measurement, Blood-Pressure, Non-Invasive
Regulation Number: DXN
Classification Product Code: KXA
Date Received: 09/28/2017
Decision Date: 06/21/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software
Manufacturer: Ngak Hwee Chua
Device Classification Name: System, Measurement, Blood-Pressure, Non-Invasive
Regulation Number: DXN
Classification Product Code: KXA
Date Received: 09/28/2017
Decision Date: 06/21/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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