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510(k) K770897

URODYNAMIC INSTRUMENTS by Life-Tech Instruments, Inc. — Product Code EXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1977
Date Received
May 16, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Uroflowmeter
Device Class
Class II
Regulation Number
876.1800
Review Panel
GU
Submission Type

Other clearances by Life-Tech Instruments, Inc.

  • K812177 — LIFE-TECH #1857 PRESSURE/POLOT MODULE (September 9, 1981)
  • K812179 — LIFE-TECH #1753 BIOFEEDBACK TRAINER (August 25, 1981)
  • K812180 — LIFE-TECH #5102 VISULAB (August 21, 1981)
  • K812178 — LIFE-TECH #'S 1106/1156 UROLABS (August 13, 1981)
  • K800112 — AMBLYOPIA TRAINER (March 10, 1980)
  • K790663 — MODEL 1750 STANDING URINAL (April 24, 1979)
  • K790664 — MODEL 1309 AUDIO MONITOR (April 23, 1979)
  • K781476 — MULAR GOLD LEAF ELECTRODE MODEL 7501 (November 15, 1978)
  • K781461 — MODEL 7320 VISUAL STIMULATOR (November 8, 1978)
  • K781474 — PREAMPLIFIER MODELS 8101PI & 8102PI (September 7, 1978)

Other clearances for product code EXY

  • K142425 — Uroflowmeter (October 27, 2014)
  • K022721 — UROPOWER (August 26, 2003)
  • K971913 — GR100F URINE FLOWMETER (September 19, 1997)
  • K953999 — DANTEC DA CAPO (November 21, 1995)
  • K951442 — FLOLAB (August 24, 1995)
  • K944972 — URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRY (March 8, 1995)
  • K945495 — 4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION (February 9, 1995)
  • K941105 — UORCAP,MODEL NUMBER UDS-UCAP (May 10, 1994)
  • K904557 — MICROFLO (December 28, 1990)
  • K902408 — DIAGNOSTIC ULTRASOUND UFS 1005 (August 10, 1990)