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FDA 510(k), K190073, Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub
FDA 510(k), K190073, Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub
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$149.00 USD
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$149.00 USD
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510(K) Number: K190073
Device Name: Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub
Manufacturer: Edwin Lindsay
Device Classification Name: System, Network And Communication, Physiological Monitors
Regulation Number: MSX
Classification Product Code: 01/16/2019
Date Received: 03/27/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub
Manufacturer: Edwin Lindsay
Device Classification Name: System, Network And Communication, Physiological Monitors
Regulation Number: MSX
Classification Product Code: 01/16/2019
Date Received: 03/27/2019
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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