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510(k) K974730

SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC) by Graphic Controls Corp. — Product Code KXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1998
Date Received
December 18, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Pressure, Intrauterine
Device Class
Class II
Regulation Number
884.2700
Review Panel
OB
Submission Type

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  • K972970 — MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE (August 27, 1997)
  • K964387 — POINT OF USE II SHARPS-A-GATOR (March 27, 1997)
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  • K963151 — MEDI-TRACE 5700 RESTING ECG ELECTRODE (November 19, 1996)
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  • 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)

Other clearances for product code KXO

  • K991235 — SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUP (July 8, 1999)
  • K982565 — EASY TRANS TIP (September 22, 1998)
  • K964279 — SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC) (January 22, 1997)
  • K961290 — IUP - TIP TRANS, IUP - PROXI TRANS (October 15, 1996)
  • K950498 — LIFE TRACE TRANS TIP INTRAUTERINE PRESSURE CATHETER (July 24, 1995)
  • K950708 — LIFETRACE INTRAUTERINE PRESSURE CATHETER IUP 3000 (May 25, 1995)
  • K922323 — MX4042/MC4044 SERIES SIMULCATH(TM) (June 14, 1994)
  • K920044 — DUAL LUMEN TRANSCERIVICAL INTRAUTERINE KIT (April 3, 1992)
  • K910742 — MEDI-TRACE DISPOSABLE INTRAUTERINE CATHETER (January 14, 1992)
  • K905563 — INTRAN PLUS (June 19, 1991)