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510(k) K871079

FETALFLEX FETAL ELECTRODE by Epcom Medical Systems, Inc. — Product Code HGP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 1987
Date Received
March 18, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Circular (Spiral), Scalp And Applicator
Device Class
Class II
Regulation Number
884.2675
Review Panel
OB
Submission Type

Other clearances by Epcom Medical Systems, Inc.

  • K910518 — GLOVE-N-GEL AMNIOTOMY KIT (May 9, 1991)
  • K905812 — INTRAUTERINE CATHETER SET (January 31, 1991)
  • K881414 — CERVICATH (June 14, 1988)
  • K844338 — 1URO-LOG HOME DIAGNOSTIC PACK (February 25, 1985)
  • K844503 — UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACK (January 2, 1985)
  • K841805 — OBSTETRICAL DOPPLER (June 19, 1984)
  • K831115 — EPCOM EMS-320 REMOTE MONITORSCOPE (August 12, 1983)
  • K831114 — EPCOM EMS-330 FREEDOM I TELEDOP OBSTET (August 12, 1983)
  • K831113 — EPCOM EMS-310 INTRAPARTUM MONITOR (August 12, 1983)
  • K831112 — EPCOM VCU-1 VACUUM SYSTEM & CURETTE (June 30, 1983)

Other clearances for product code HGP

  • K243291 — Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) (January 17, 2025)
  • K030691 — FETAL SPIRAL ELECTRODE, MODEL FSE07000 (September 17, 2003)
  • K003458 — SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000 (May 3, 2001)
  • K943732 — LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE (October 20, 1994)
  • K910815 — CR SPIRAL ELECTRODE (December 10, 1991)
  • K911657 — FETAL SCALP SPIRAL ELECTRODE (July 11, 1991)
  • K905830 — COMBO FETAL SCALP ELECTRODE/LEGPLATE (March 29, 1991)
  • K905130 — FETAL MONITORING SPIRAL ELECTRODE (January 29, 1991)
  • K904745 — MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE (January 29, 1991)
  • K901152 — REDYPLATE DISPOSABLE LEG PLATE (April 4, 1990)