510(k) K092408

RHYTHM OF LIFE, MODEL R0901-05 by Rapid Response Solutions, LLC — Product Code LIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 2009
Date Received
August 6, 2009
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