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FDA 510(k), K190693, HEM-6410T-ZL Wrist Blood Pressure Monitor
FDA 510(k), K190693, HEM-6410T-ZL Wrist Blood Pressure Monitor
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$149.00 USD
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$149.00 USD
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510(K) Number: K190693
Device Name: HEM-6410T-ZL Wrist Blood Pressure Monitor
Manufacturer: Renee Thornborough
Device Classification Name: System, Measurement, Blood-Pressure, Non-Invasive
Regulation Number: DXN
Classification Product Code: 03/18/2019
Date Received: 04/17/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: HEM-6410T-ZL Wrist Blood Pressure Monitor
Manufacturer: Renee Thornborough
Device Classification Name: System, Measurement, Blood-Pressure, Non-Invasive
Regulation Number: DXN
Classification Product Code: 03/18/2019
Date Received: 04/17/2019
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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