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510(k) K983196

PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) by Tz Medical, Inc. — Product Code DRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 1999
Date Received
September 11, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Device Class
Class II
Regulation Number
870.5550
Review Panel
CV
Submission Type

Other clearances by Tz Medical, Inc.

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  • K102507 — AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR (June 13, 2011)
  • K062577 — V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPC (December 15, 2006)
  • K040208 — NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND (May 11, 2004)
  • K021421 — PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CONNECTOR & CABLE (April 18, 2003)
  • K001634 — CARDIOSENTRY EVENT MONITOR, MODEL 8470-01 (December 21, 2000)
  • K993205 — BOOKER BOX, MODEL PAD 5010 (July 20, 2000)
  • K983232 — PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2 (September 15, 1999)
  • K982228 — FM DEMODULATOR-4 LEAD MODEL #8500-05 AND FM DEMODULATOR-12 LEAD MODEL # 8500-25 (January 14, 1999)

Other clearances for product code DRO

  • K012404 — K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 (October 12, 2001)
  • K012218 — LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES (October 12, 2001)
  • K000660 — ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS (March 28, 2000)
  • K983232 — PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2 (September 15, 1999)
  • K974034 — PORTABLE INTENSIVE CARE UNIT (March 2, 1998)
  • K962547 — CARDIOSERV P (March 6, 1997)
  • K963120 — RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM (February 28, 1997)
  • K961138 — ESORT II + 400 SERIES MONITOR (December 10, 1996)
  • K951593 — LIFEPAK 11 (December 29, 1995)
  • K950856 — ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000 ADVISORY (December 29, 1995)