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FDA 510(k), K201456, Scan Monitor
FDA 510(k), K201456, Scan Monitor
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$149.00 USD
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510(K) Number: K201456
Device Name: Scan Monitor
Manufacturer: Debreuil Xavier
Device Classification Name: Electrocardiograph
Regulation Number: DPS
Classification Product Code: 06/01/2020
Date Received: 10/05/2021
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: Scan Monitor
Manufacturer: Debreuil Xavier
Device Classification Name: Electrocardiograph
Regulation Number: DPS
Classification Product Code: 06/01/2020
Date Received: 10/05/2021
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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