Cleared Traditional

CPR RSQ ASSIST

K123248 · Avantech, Inc. · Cardiovascular

Dec 2013

Decision

419d

Days

Class 2

Risk

About This 510(k) Submission

K123248 is an FDA 510(k) clearance for the CPR RSQ ASSIST, a Aid, Cardiopulmonary Resuscitation (Class II — Special Controls, product code LIX), submitted by Avantech, Inc. (Philedelphia, US). The FDA issued a Cleared decision on December 10, 2013, 419 days after receiving the submission on October 17, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5210.

Submission Details

510(k) Number	K123248 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 17, 2012
Decision Date	December 10, 2013
Days to Decision	419 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	LIX — Aid, Cardiopulmonary Resuscitation
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.5210
Definition	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