FDA 510(k), K151911, WorkMate Claris System, WorkMate Claris System Display Plus

FDA 510(k), K151911, WorkMate Claris System, WorkMate Claris System Display Plus

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510(K) Number: K151911
Device Name: WorkMate Claris System, WorkMate Claris System Display Plus
Manufacturer: MELISSA FRANK
Device Classification Name: Computer, Diagnostic, Programmable
Regulation Number: DQK
Classification Product Code: KXA
Date Received: 07/13/2015
Decision Date: 10/22/2015
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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