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510(k) K895763

ISOFLO AND ISOTEC INTRAUTERINE PRESSURE MONITORING by Healthdyne Cardiovascular, Inc. — Product Code KXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1989
Date Received
September 26, 1989
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

Other clearances by Healthdyne Cardiovascular, Inc.

  • K901643 — ISOFLO(TM) AMNIOCENTESIS TRAY (July 25, 1990)
  • K901382 — ISOFLO(TM) HIGH PRESSURE INJECTION LINES (July 19, 1990)
  • K901084 — ISOFLO INTRAUTERINE PRESSURE MONITORING & AMNIO. (June 1, 1990)
  • K900665 — DRESSING CHANGE KIT (May 14, 1990)

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)
  • K974730 — SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUP (July 14, 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)