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510(k) K813275

EPCOM EMS SCAN II by Epcom Medical Systems, Inc. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1982
Date Received
November 23, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
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)
  • 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)

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