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510(k) K920992

PROFILE PLUS URODYNAMICS MEASURING SYST, MODIFIED by Browne Medical Systems, Inc. — Product Code FAP

K920992 is an FDA 510(k) premarket notification submitted by Browne Medical Systems, Inc. for the device "PROFILE PLUS URODYNAMICS MEASURING SYST, MODIFIED". The FDA issued a decision of Substantially Equivalent on April 10, 1992. The device falls under product code FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device), a Class II device regulated under 21 CFR 876.1620. Browne Medical Systems, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1992
Date Received
February 14, 1992
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 Browne Medical Systems, Inc.

  • K921047 — MODEL 8100 URODYNAMICS MEASURING SYSTEM (April 10, 1992)
  • K920991 — IMAGE PRO URODYNAMICS MEASURING SYST, MODIFICATION (April 10, 1992)
  • K910444 — BROWNE MEDICAL SYSTEMS IMAGEPRO (June 10, 1991)
  • K910371 — URODYNAMIC MEASURING SYSTEM (May 15, 1991)
  • K910217 — MINIPRO 8100 URODYNAMIC MEASUREING SYSTEM (April 2, 1991)
  • K910285 — BROWNE MEDICAL SYST.INC STAND-ALONE WATER PUMP (April 2, 1991)

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)

FDA data resources