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510(k) K833043

UROMETER by Browne Medical, Inc. — Product Code FFG

K833043 is an FDA 510(k) premarket notification submitted by Browne Medical, Inc. for the device "UROMETER". The FDA issued a decision of Substantially Equivalent on February 4, 1984. 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. Browne Medical, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1984
Date Received
September 6, 1983
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 Browne Medical, Inc.

  • K851483 — UROBEI STRESS INCONTINENCE MONITOR (August 7, 1985)
  • K834503 — PROFILE URODYNAMIC MONITORING SYS (February 21, 1984)
  • K830221 — BEDSIDE N.P.T. 9900 - PRINTER 9800 (March 17, 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)
  • K844338 — 1URO-LOG HOME DIAGNOSTIC PACK (February 25, 1985)
  • K843441 — URINARY DRAINAGE CONTAINER 2012-WITH (January 3, 1985)
  • K843442 — URINARY DRAINAGE CONTAINER 2013 WITH (January 3, 1985)
  • K844030 — ACCUMETER ELECTRONIC URINEMETER SYSTEM (November 20, 1984)
  • K843224 — UROPUMP MODEL 1711 (October 19, 1984)
  • K813641 — VITAL METRICS URINE MONITORING SYSTEM (March 1, 1982)
  • K813082 — UREOFIX 500 URINE MEASURING SYSTEM (December 31, 1981)

FDA data resources