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510(k) K801758

MMI/GAELTEC CATHETER INTRAUTERINE by Medical Measurements, Inc. — Product Code KXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 1980
Date Received
July 28, 1980
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 Medical Measurements, Inc.

  • K921062 — GAELTEC MPR SERIES (July 30, 1992)
  • K902097 — MODEL TR RECTAL SUCTION BIOPSY TUBE (July 27, 1990)
  • K863479 — MODIFIED ICT/B INTRACRANIAL PRESS. TRANS. EPIDURAL (October 14, 1986)
  • K801757 — MMI/GAELTEC CATHETER TIP PRESS. TRANSDU (August 27, 1980)
  • K801756 — MMI/GAELTEC CATHETER TIP TRANSDUC (August 20, 1980)
  • K801880 — MMI/GAELTEC SERIES 8T DIFF. PRESS. TRANS (August 14, 1980)
  • K801755 — MMI/GAELTEC CATHETER TIP PRESSURE (August 13, 1980)

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)