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510(k) K112660

POCKETCPR by Zoll Medical Corp — Product Code LIX

K112660 is an FDA 510(k) premarket notification submitted by Zoll Medical Corp for the device "POCKETCPR". The FDA issued a decision of Substantially Equivalent on May 10, 2012. The device falls under product code LIX (Aid, Cardiopulmonary Resuscitation), a Class II device regulated under 21 CFR 870.5210. Zoll Medical Corp has at least 10 other 510(k) clearances on record.

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)

FDA data resources