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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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$89.00 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: KXA
Date Received: 01/16/2019
Decision Date: 03/27/2019
Decision: 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: KXA
Date Received: 01/16/2019
Decision Date: 03/27/2019
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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