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510(k) K983287

MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE by Graphic Controls Corp. — Product Code MKJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1998
Date Received
September 18, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Automated External Defibrillators (Non-Wearable)
Device Class
Class III
Regulation Number
870.5310
Review Panel
CV
Submission Type

This device is a non-wearable prescription use only aed. These are devices that include automated external defibrillation. Automated external defibrillators use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation. These devices are intended to be used on suspected victims of sudden cardiac arrest. A person in cardiac arrest is unresponsive and is not breathing normally. The device can be sold with prescription only.

Other clearances by Graphic Controls Corp.

  • K981964 — MEDI-TRACE 4103 NEONATAL ELECTRODE (November 13, 1998)
  • K974730 — SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUP (July 14, 1998)
  • K980857 — MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODE (May 12, 1998)
  • K972970 — MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE (August 27, 1997)
  • K964387 — POINT OF USE II SHARPS-A-GATOR (March 27, 1997)
  • K964279 — SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC) (January 22, 1997)
  • K963151 — MEDI-TRACE 5700 RESTING ECG ELECTRODE (November 19, 1996)
  • K963038 — MEDI-TRACE 3600 SERIES OF ECG MONITORING ELECTRODE (November 15, 1996)
  • K960968 — MEDI-TRACE 200, MEDI-TRACE 200-30 (October 28, 1996)
  • K955882 — MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR HEWLETT PACKARD DEFIBR (October 24, 1996)

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  • K142709 — samaritan PAD 450P (March 27, 2015)
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  • K142430 — LIFEPAK 15 monitor/defibrillator (December 19, 2014)
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