510(k) K071321

POCKETCPR by Bio-Detek, Inc. — Product Code LIX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 12, 2007
Date Received: May 10, 2007
Clearance Type: Traditional
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 Bio-Detek, Inc.

K150055 — OneStep Pediatric CPR Multi-Function Electrode (May 2, 2015)
K150198 — CPR Dura-Padz Reusable Defibrillation Electrode with Dura-padz Gel (May 2, 2015)
K133441 — ONESTEP CPR II MULTI-FUNCTION ELECTRODE (October 10, 2014)
K100565 — DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0 (November 16, 2010)
K040256 — PEDI-PADZ RADIOLUCENT MULTI-FUNCTION PEDIATRIC ELECTRODES, MODEL 8900-1005 (April 9, 2004)
K040056 — BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90 (April 9, 2004)
K033771 — BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTOR (February 27, 2004)
K984582 — ZOLL SUPERPADZ ADULT MULTI-FUNCTION ELECTRODES, MODEL 8900-XXXX (March 16, 1999)
K990106 — ZOLL FIRST RESPONDER PADZ ADULT DEFIBRILLATION ELECTRODES (February 26, 1999)
K981802 — ZOLL STAT*PADZ ADULT MULTI-FUNCTION ELECTRODES MODEL NUMBER 8900-4003 (November 25, 1998)

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)
K112660 — POCKETCPR (May 10, 2012)
K092408 — RHYTHM OF LIFE, MODEL R0901-05 (October 14, 2009)
K010526 — MODIFICATION TO THE GRIP (December 13, 2001)