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510(k) K770579

CATHETER, URETHRAL PRESSURE, UPE-10 & 12 by Life-Tech Instruments, Inc. — Product Code FAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1977
Date Received
March 28, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
Device Class
Class II
Regulation Number
876.1620
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 FAP

  • K113771 — SIGNAL GEAR URETHRAL CATHETER ELECTRODE (December 13, 2012)
  • K974775 — SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE (February 19, 1998)
  • K963330 — URODYNAMIC ANALYSIS MODULE (April 3, 1997)
  • K962472 — RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER (August 27, 1996)
  • K931175 — SCHUSTER DISPOSABLE BALLOON PROBE (April 1, 1994)
  • K931179 — UROLAB SPECTRUM (November 18, 1993)
  • K922476 — URO-PRO 2000 (July 20, 1993)
  • K924383 — SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO (June 18, 1993)
  • K923995 — URODYNAMICS TUBING KITS #5161, #5150, #7170 (April 8, 1993)
  • K923464 — URODYNAMIC CATHETERS (February 5, 1993)