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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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$149.00 USD
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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: 09/28/2017
Date Received: 06/21/2018
Decision Date: 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: 09/28/2017
Date Received: 06/21/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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