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FDA 510(k), K191323, Carescape B850
FDA 510(k), K191323, Carescape B850
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$149.00 USD
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510(K) Number: K191323
Device Name: Carescape B850
Manufacturer: Joel Kent
Device Classification Name: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Regulation Number: MHX
Classification Product Code: 05/15/2019
Date Received: 01/29/2020
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: Carescape B850
Manufacturer: Joel Kent
Device Classification Name: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Regulation Number: MHX
Classification Product Code: 05/15/2019
Date Received: 01/29/2020
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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