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FDA 510(k), K201456, Scan Monitor
FDA 510(k), K201456, Scan Monitor
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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: KXA
Date Received: 06/01/2020
Decision Date: 10/05/2021
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: Scan Monitor
Manufacturer: Debreuil Xavier
Device Classification Name: Electrocardiograph
Regulation Number: DPS
Classification Product Code: KXA
Date Received: 06/01/2020
Decision Date: 10/05/2021
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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