FDA 510(k), K223290, CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)

FDA 510(k), K223290, CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)

Regular price $49.00 USD
Regular price Sale price $49.00 USD
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510(K) Number: K223290
Device Name: CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)
Manufacturer: Alexander Schreiner
Device Classification Name: System, Image Processing, Radiological
Regulation Number: LLZ
Classification Product Code: KXA
Date Received: 10/26/2022
Decision Date: 07/14/2023
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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