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510(k) K930171

FST DUAL, DUAL PRESSURE URODYNAMICS MONITOR by Fiberoptic Sensor Technlogies, Inc. — Product Code FEN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 1993
Date Received
January 13, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Cystometric, Hydraulic
Device Class
Class II
Regulation Number
876.1620
Review Panel
GU
Submission Type

Other clearances by Fiberoptic Sensor Technlogies, Inc.

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  • K950908 — FST CATH-UD, CATHETER (April 7, 1995)
  • K945495 — 4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION (February 9, 1995)
  • 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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