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510(k) K021421

PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CONNECTOR & CABLE by Tz Medical, Inc. — Product Code DRF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 2003
Date Received
May 3, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class
Class II
Regulation Number
870.1220
Review Panel
CV
Submission Type

Other clearances by Tz Medical, Inc.

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  • 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)
  • K001634 — CARDIOSENTRY EVENT MONITOR, MODEL 8470-01 (December 21, 2000)
  • K993205 — BOOKER BOX, MODEL PAD 5010 (July 20, 2000)
  • K983196 — PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) (September 15, 1999)
  • 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)

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