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510(k) K911125

DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020 by Diagnostic Ultrasound Corp. — Product Code FAP

K911125 is an FDA 510(k) premarket notification submitted by Diagnostic Ultrasound Corp. for the device "DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020". The FDA issued a decision of Substantially Equivalent on August 15, 1991. The device falls under product code FAP (Cystometric Gas (Carbon-Dioxide) On Hydraulic Device), a Class II device regulated under 21 CFR 876.1620. Diagnostic Ultrasound Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1991
Date Received
March 13, 1991
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 Diagnostic Ultrasound Corp.

  • K030763 — DIAGNOSTIC ULTRASOUND BLADDERMASS BVM 6500 ULTRASOUND SYSTEM (March 26, 2003)
  • K022153 — BLADDERSCAN BVI 6100 (August 15, 2002)
  • K982568 — BLADDERMANAGER PCI 5000 MODEL 1002 (January 25, 1999)
  • K963585 — BLADDER MANAGER PCI 5000, BLADDERSCAN BVI 5000 (October 1, 1996)
  • K955840 — BLADDERMANAGER PCI 5000 / BLADDERSCAN BVI 5000 (May 24, 1996)
  • K955942 — BLADDERSCAN BVI 5000 (March 15, 1996)
  • K920664 — DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020, GI VERSION (December 23, 1993)
  • K915342 — UD 2000 VIDEO OPTION (June 10, 1992)
  • K915436 — BLADDERSCAN BVI 2500 (March 3, 1992)
  • K911166 — DIAGNOSTIC ULTRASOUND/URO-GYN UD 511 (August 15, 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