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510(k) K982228

FM DEMODULATOR-4 LEAD MODEL #8500-05 AND FM DEMODULATOR-12 LEAD MODEL # 8500-25 by Tz Medical, Inc. — Product Code DXH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1999
Date Received
June 25, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Device Class
Class II
Regulation Number
870.2920
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)
  • 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)

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