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510(k) K960968

MEDI-TRACE 200, MEDI-TRACE 200-30 by Graphic Controls Corp. — Product Code DRX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1996
Date Received
March 11, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Electrocardiograph
Device Class
Class II
Regulation Number
870.2360
Review Panel
CV
Submission Type

Other clearances by Graphic Controls Corp.

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  • 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)
  • K955882 — MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR HEWLETT PACKARD DEFIBR (October 24, 1996)

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