Cleared Traditional

TRUECPR COACHING DEVICE

K123597 · Physio-Control, Inc. · Cardiovascular

Apr 2013

Decision

147d

Days

Class 2

Risk

About This 510(k) Submission

K123597 is an FDA 510(k) clearance for the TRUECPR COACHING DEVICE, a Aid, Cardiopulmonary Resuscitation (Class II — Special Controls, product code LIX), submitted by Physio-Control, Inc. (Redmond, US). The FDA issued a Cleared decision on April 17, 2013, 147 days after receiving the submission on November 21, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5210.

Submission Details

510(k) Number	K123597 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 21, 2012
Decision Date	April 17, 2013
Days to Decision	147 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