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FDA Product Code

FDA Product Code LIX — Clearance Directory

Device Class
Class II
Assigned Panel
Cardiovascular
21 CFR Citation
870.5210

510(k) Clearances — 17 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K201581 CPR BAND Credo 2021-03-06 Traditional PDF ↗
K183348 Reusable Silicone Cover CPRmeter 2 Laerdal Medical AS 2018-12-17 Special PDF ↗
K173886 CPRmeter 2 CPR Feedback Device Laerdal Medical AS 2018-03-23 Traditional PDF ↗
K151702 Reusable Full Silicone Cover Laerdal Medical AS 2015-08-13 Special PDF ↗
K123248 CPR RSQ ASSIST Avantech, Inc. 2013-12-10 Traditional PDF ↗
K123597 TRUECPR COACHING DEVICE Physio-Control, Inc. 2013-04-17 Traditional PDF ↗
K122050 CPRMETER CPR FEEDBACK DEVICE Laerdal Medical A/S 2012-10-22 Traditional PDF ↗
K112660 POCKETCPR Zoll Medical Corp 2012-05-10 Abbreviated PDF ↗
K092408 RHYTHM OF LIFE, MODEL R0901-05 Rapid Response Solutions, LLC 2009-10-14 Traditional PDF ↗
K071321 POCKETCPR Bio-Detek, Inc. 2007-09-12 Traditional PDF ↗
K010526 MODIFICATION TO THE GRIP Elcare Innovations, Inc. 2001-12-13 Traditional PDF ↗
K003937 CPR EZY MASK AND PAD Medteq Innovations Pty, Ltd. 2001-06-06 Traditional PDF ↗
K954692 CPR PROMPT County Line , Ltd. 1996-03-27 Traditional PDF ↗
K926333 CPR PLUS Kells Medical, Inc. 1993-11-08 Traditional PDF ↗
K900415 C.P.R. LANDMARC Can-Am Medical, Inc. 1990-06-12 Traditional PDF ↗
K843977 PULSE-AID DEVICE James J. Lally 1985-02-01 Traditional PDF ↗
K833737 CPR LOCATOR Lifepoint,Inc 1984-08-24 Traditional PDF ↗

Product code LIX · Class II · Cardiovascular. Data: openFDA.