Cleared Special

Reusable Full Silicone Cover

K151702 · Laerdal Medical AS · Cardiovascular
Aug 2015
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K151702 is an FDA 510(k) clearance for the Reusable Full Silicone Cover, 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 August 13, 2015, 50 days after receiving the submission on June 24, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5210.

Submission Details

510(k) Number K151702 FDA.gov
FDA Decision Cleared SESE
Date Received June 24, 2015
Decision Date August 13, 2015
Days to Decision 50 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