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510(k) K841805

OBSTETRICAL DOPPLER by Epcom Medical Systems, Inc. — Product Code KNG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 1984
Date Received
May 1, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Ultrasonic, Fetal
Device Class
Class II
Regulation Number
884.2660
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)
  • K871079 — FETALFLEX FETAL ELECTRODE (July 13, 1987)
  • K844338 — 1URO-LOG HOME DIAGNOSTIC PACK (February 25, 1985)
  • K844503 — UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACK (January 2, 1985)
  • 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 KNG

  • K252669 — Fetal Doppler U8-25, U9-25 (January 8, 2026)
  • K242846 — Doppler FHR Detector (BF-500D+, BF-560) (June 26, 2025)
  • K233823 — Ultrasonic Fetal Doppler (June 28, 2024)
  • K232893 — Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fet (June 14, 2024)
  • K220245 — Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) (September 28, 2022)
  • K211940 — Fetal Doppler (January 7, 2022)
  • K212084 — Fetal Doppler (November 3, 2021)
  • K191110 — HeraBEAT™ US (November 14, 2019)
  • K182526 — Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD- (May 29, 2019)
  • K182710 — Fetal Doppler, Model FD88 (March 1, 2019)