Cleared Traditional

CPRMETER CPR FEEDBACK DEVICE

K122050 · Laerdal Medical A/S · Cardiovascular

Oct 2012

Decision

102d

Days

Class 2

Risk

About This 510(k) Submission

K122050 is an FDA 510(k) clearance for the CPRMETER CPR FEEDBACK DEVICE, a Aid, Cardiopulmonary Resuscitation (Class II — Special Controls, product code LIX), submitted by Laerdal Medical A/S (West Lafayette, US). The FDA issued a Cleared decision on October 22, 2012, 102 days after receiving the submission on July 12, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5210.

Submission Details

510(k) Number	K122050 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 12, 2012
Decision Date	October 22, 2012
Days to Decision	102 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