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510(k) K902408

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

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

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  • 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)
  • K911125 — DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020 (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)