Cleared Traditional

CPRmeter 2 CPR Feedback Device

K173886 · Laerdal Medical AS · Cardiovascular
Mar 2018
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K173886 is an FDA 510(k) clearance for the CPRmeter 2 CPR Feedback Device, a Aid, Cardiopulmonary Resuscitation (Class II — Special Controls, product code LIX), submitted by Laerdal Medical AS (Stavanger, NO). The FDA issued a Cleared decision on March 23, 2018, 92 days after receiving the submission on December 21, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5210.

Submission Details

510(k) Number K173886 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 2017
Decision Date March 23, 2018
Days to Decision 92 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