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510(k) K945495

4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION by Fiberoptic Sensor Technlogies, Inc. — Product Code EXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 1995
Date Received
November 8, 1994
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 Fiberoptic Sensor Technlogies, Inc.

  • K945753 — FST FIBEROPTIC PRESSURE CONVERTER (May 11, 1995)
  • K950908 — FST CATH-UD, CATHETER (April 7, 1995)
  • K930171 — FST DUAL, DUAL PRESSURE URODYNAMICS MONITOR (November 4, 1993)
  • K922776 — FST COUNCIL TIP FOLEY CATHETER (July 20, 1993)
  • K922476 — URO-PRO 2000 (July 20, 1993)
  • K926088 — FST CATH UD-DUAL DUAL PRESSURE CATHETER (June 18, 1993)
  • K913113 — FST CATH-UD CATHETER, MODIFICATION (October 9, 1991)
  • K913721 — FST CATH - UI USRODYNAMIC CATH INTRODUCER SYSTEM (October 8, 1991)
  • K905641 — FST CATH-UD CATHETER (February 19, 1991)
  • K864000 — FST DISPOSABLE FIBER OPTIC TRANSDUCER #0100-00 (January 16, 1987)

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  • K953999 — DANTEC DA CAPO (November 21, 1995)
  • K951442 — FLOLAB (August 24, 1995)
  • K944972 — URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRY (March 8, 1995)
  • K941105 — UORCAP,MODEL NUMBER UDS-UCAP (May 10, 1994)
  • K904557 — MICROFLO (December 28, 1990)
  • K902408 — DIAGNOSTIC ULTRASOUND UFS 1005 (August 10, 1990)
  • K900770 — HOME URODATA SYSTEM(TM) (June 8, 1990)