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FDA 510(k), K182481, HEM-6410T-ZM Wrist Blood Pressure Monitor
FDA 510(k), K182481, HEM-6410T-ZM 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: K182481
Device Name: HEM-6410T-ZM Wrist Blood Pressure Monitor
Manufacturer: Omron Healthcare, Inc.
Device Classification Name: system, measurement, blood-pressure, non-invasive
Regulation Number: 870.1130
Classification Product Code: DXN
Date Received: 09/10/2018
Decision Date: 11/09/2018
Regulation Medical Specialty: Cardiovascular
Device Name: HEM-6410T-ZM Wrist Blood Pressure Monitor
Manufacturer: Omron Healthcare, Inc.
Device Classification Name: system, measurement, blood-pressure, non-invasive
Regulation Number: 870.1130
Classification Product Code: DXN
Date Received: 09/10/2018
Decision Date: 11/09/2018
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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