Cleared Special

Reusable Silicone Cover CPRmeter 2

K183348 · Laerdal Medical AS · Cardiovascular
Dec 2018
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K183348 is an FDA 510(k) clearance for the Reusable Silicone Cover CPRmeter 2, 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 December 17, 2018, 14 days after receiving the submission on December 3, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5210.

Submission Details

510(k) Number K183348 FDA.gov
FDA Decision Cleared SESE
Date Received December 03, 2018
Decision Date December 17, 2018
Days to Decision 14 days
Submission Type Special
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