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510(k) K902408

DIAGNOSTIC ULTRASOUND UFS 1005 by Diagnostic Ultrasound Corp. — Product Code EXY

K902408 is an FDA 510(k) premarket notification submitted by Diagnostic Ultrasound Corp. for the device "DIAGNOSTIC ULTRASOUND UFS 1005". The FDA issued a decision of Substantially Equivalent on August 10, 1990. The device falls under product code EXY (Uroflowmeter), a Class II device regulated under 21 CFR 876.1800. Diagnostic Ultrasound Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1990
Date Received
May 31, 1990
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 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 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)
  • K900770 — HOME URODATA SYSTEM(TM) (June 8, 1990)

FDA data resources