510(k) K112660

POCKETCPR by Zoll Medical Corp — Product Code LIX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 10, 2012
Date Received: September 13, 2011
Clearance Type: Abbreviated
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Aid, Cardiopulmonary Resuscitation
Device Class: Class II
Regulation Number: 870.5210
Review Panel: CV
Submission Type

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

Other clearances by Zoll Medical Corp

K133484 — ZOLL X SERIES (August 1, 2014)
K090989 — ZOLL R SERIES WITH NIBP AND ETCO2 OPTIONS, ZOLL R SERIES (September 23, 2009)
K042007 — ZOLL E SERIES DEFIBRILLATOR (April 7, 2005)
K042302 — ZOLL AUTOCLAVABLE INTERNAL HANDLES, ZOLL AUTOCLAVABLE INTERNAL HANDLES WITH INTE (October 26, 2004)
K042417 — ZOLL M SERIES ETC02 LOFLO OPTION (October 5, 2004)
K033474 — ZOLL AED PLUS (May 21, 2004)
K032691 — ZOLL AUTOCLAVABLE INTERNAL HANDLES (November 13, 2003)
K032439 — ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC) (November 5, 2003)
K032363 — ZOLL M SERIES NIBP OPTION (October 31, 2003)
K011541 — ZOLL PAD WITH CPR AID (April 11, 2002)

Other clearances for product code LIX

K201581 — CPR BAND (March 6, 2021)
K183348 — Reusable Silicone Cover CPRmeter 2 (December 17, 2018)
K173886 — CPRmeter 2 CPR Feedback Device (March 23, 2018)
K151702 — Reusable Full Silicone Cover (August 13, 2015)
K123248 — CPR RSQ ASSIST (December 10, 2013)
K123597 — TRUECPR COACHING DEVICE (April 17, 2013)
K122050 — CPRMETER CPR FEEDBACK DEVICE (October 22, 2012)
K092408 — RHYTHM OF LIFE, MODEL R0901-05 (October 14, 2009)
K071321 — POCKETCPR (September 12, 2007)
K010526 — MODIFICATION TO THE GRIP (December 13, 2001)