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LIX — Aid, Cardiopulmonary Resuscitation Class II

FDA Device Classification

Classification Details

Product Code
LIX
Device Class
Class II
Regulation Number
870.5210
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K201581credoCPR BANDMarch 6, 2021
K183348laerdal medicalReusable Silicone Cover CPRmeter 2December 17, 2018
K173886laerdal medicalCPRmeter 2 CPR Feedback DeviceMarch 23, 2018
K151702laerdal medicalReusable Full Silicone CoverAugust 13, 2015
K123248avantechCPR RSQ ASSISTDecember 10, 2013
K123597physio-controlTRUECPR COACHING DEVICEApril 17, 2013
K122050laerdal medicalCPRMETER CPR FEEDBACK DEVICEOctober 22, 2012
K112660zoll medicalPOCKETCPRMay 10, 2012
K092408rapid response solutionsRHYTHM OF LIFE, MODEL R0901-05October 14, 2009
K071321bio-detekPOCKETCPRSeptember 12, 2007
K010526elcare innovationsMODIFICATION TO THE GRIPDecember 13, 2001
K003937medteq innovations ptyCPR EZY MASK AND PADJune 6, 2001
K954692county lineCPR PROMPTMarch 27, 1996
K926333kells medicalCPR PLUSNovember 8, 1993
K900415can-am medicalC.P.R. LANDMARCJune 12, 1990
K843977james j. lallyPULSE-AID DEVICEFebruary 1, 1985
K833737lifepointCPR LOCATORAugust 24, 1984