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, Elcare Innovations, Inc. and Bio-Detek, Inc..

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
Cleared Aug 13, 2015
Reusable Full Silicone Cover
K151702
Laerdal Medical AS
Cardiovascular · 50d
Cleared Dec 10, 2013
CPR RSQ ASSIST
K123248
Avantech, Inc.
Cardiovascular · 419d
Cleared Apr 17, 2013
TRUECPR COACHING DEVICE
K123597
Physio-Control, Inc.
Cardiovascular · 147d
Cleared Oct 22, 2012
CPRMETER CPR FEEDBACK DEVICE
K122050
Laerdal Medical A/S
Cardiovascular · 102d
Cleared May 10, 2012
POCKETCPR
K112660
Zoll Medical Corp
Cardiovascular · 240d
Cleared Oct 14, 2009
RHYTHM OF LIFE, MODEL R0901-05
K092408
Rapid Response Solutions, LLC
Cardiovascular · 69d
Cleared Sep 12, 2007
POCKETCPR
K071321
Bio-Detek, Inc.
Cardiovascular · 125d
Cleared Dec 13, 2001
MODIFICATION TO THE GRIP
K010526
Elcare Innovations, Inc.
Cardiovascular · 294d
Cleared Jun 06, 2001
CPR EZY MASK AND PAD
K003937
Medteq Innovations Pty, Ltd.
Cardiovascular · 168d
Cleared Mar 27, 1996
CPR PROMPT
K954692
County Line , Ltd.
Cardiovascular · 168d

About Product Code LIX - Regulatory Context