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FDA 510(k), K182543, Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package
FDA 510(k), K182543, Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package
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510(K) Number: K182543
Device Name: Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package
Manufacturer: Edwin Lindsay
Device Classification Name: System, Network And Communication, Physiological Monitors
Regulation Number: MSX
Classification Product Code: 09/17/2018
Date Received: 11/14/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package
Manufacturer: Edwin Lindsay
Device Classification Name: System, Network And Communication, Physiological Monitors
Regulation Number: MSX
Classification Product Code: 09/17/2018
Date Received: 11/14/2018
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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