FDA 510(k), K213863, Everion+ System

FDA 510(k), K213863, Everion+ System

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510(K) Number: K213863
Device Name: Everion+ System
Manufacturer: Milan Shah
Device Classification Name: System, Network And Communication, Physiological Monitors
Regulation Number: MSX
Classification Product Code: KXA
Date Received: 12/10/2021
Decision Date: 02/23/2023
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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