LIX · Class II · 21 CFR 870.5210

FDA Product Code LIX: Aid, Cardiopulmonary Resuscitation

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

Leading manufacturers include Laerdal Medical AS and Credo.

17
Total
17
Cleared
179d
Avg days
1984
Since

FDA 510(k) Cleared Aid, Cardiopulmonary Resuscitation Devices (Product Code LIX)

17 devices
1–17 of 17
Cleared Mar 06, 2021
CPR BAND
K201581
Credo
Cardiovascular · 268d
Cleared Dec 17, 2018
Reusable Silicone Cover CPRmeter 2
K183348
Laerdal Medical AS
Cardiovascular · 14d
Cleared Mar 23, 2018
CPRmeter 2 CPR Feedback Device
K173886
Laerdal Medical AS
Cardiovascular · 92d

About Product Code LIX - Regulatory Context