510(k) K123248

CPR RSQ ASSIST by Avantech, Inc. — Product Code LIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2013
Date Received
October 17, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Aid, Cardiopulmonary Resuscitation
Device Class
Class II
Regulation Number
870.5210
Review Panel
CV
Submission Type

CPR Aid device WITH feedback (visual, audio or both) on one or more CPR parameters (e.g., rate, depth, ventilation ratio, etc.), and contains software. Provides real-time feedback on CPR performance. Feedback can be audio, visual or both. Device contains software