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510(k) K844338

1URO-LOG HOME DIAGNOSTIC PACK by Epcom Medical Systems, Inc. — Product Code FFG

K844338 is an FDA 510(k) premarket notification submitted by Epcom Medical Systems, Inc. for the device "1URO-LOG HOME DIAGNOSTIC PACK". The FDA issued a decision of Substantially Equivalent on February 25, 1985. The device falls under product code FFG (Device, Urine Flow Rate Measuring, Non-Electrical, Disposable), a Class II device regulated under 21 CFR 876.1800. Epcom Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1985
Date Received
November 8, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Urine Flow Rate Measuring, Non-Electrical, Disposable
Device Class
Class II
Regulation Number
876.1800
Review Panel
GU
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)
  • K844503 — UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACK (January 2, 1985)
  • K841805 — OBSTETRICAL DOPPLER (June 19, 1984)
  • K831113 — EPCOM EMS-310 INTRAPARTUM MONITOR (August 12, 1983)
  • K831115 — EPCOM EMS-320 REMOTE MONITORSCOPE (August 12, 1983)
  • K831114 — EPCOM EMS-330 FREEDOM I TELEDOP OBSTET (August 12, 1983)
  • K831112 — EPCOM VCU-1 VACUUM SYSTEM & CURETTE (June 30, 1983)

Other clearances for product code FFG

  • K893827 — PEAK FLOW RATE METER (August 11, 1989)
  • K883274 — SURGITEK (R) UROFLOW SYSTEM (February 8, 1989)
  • K850169 — ERIS URO-DIAGNOSTIC SYSTEM (April 22, 1985)
  • K843442 — URINARY DRAINAGE CONTAINER 2013 WITH (January 3, 1985)
  • K843441 — URINARY DRAINAGE CONTAINER 2012-WITH (January 3, 1985)
  • K844030 — ACCUMETER ELECTRONIC URINEMETER SYSTEM (November 20, 1984)
  • K843224 — UROPUMP MODEL 1711 (October 19, 1984)
  • K833043 — UROMETER (February 4, 1984)
  • K813641 — VITAL METRICS URINE MONITORING SYSTEM (March 1, 1982)
  • K813082 — UREOFIX 500 URINE MEASURING SYSTEM (December 31, 1981)

FDA data resources