Medical Device Manufacturer · US , Plymouth , MI

Fiberoptic Sensor Technlogies, Inc.

11 submissions · 11 cleared · Since 1987
11
Total
11
Cleared
0
Denied

Fiberoptic Sensor Technlogies, Inc. — FDA 510(k) Submissions

Fiberoptic Sensor Technlogies, Inc. has submitted 11 FDA 510(k) premarket notifications since 1987, of which 11 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Device, Cystometric, Hydraulic, Transducer, Pressure, Catheter Tip, Cystometric Gas (carbon-dioxide) On Hydraulic Device, Uroflowmeter . Use the specialty filter in the sidebar to narrow results.

11 devices
1–11 of 11
FST FIBEROPTIC PRESSURE CONVERTER
K945753 · FEN Device, Cystometric,... · Gastroenterology & Urology
May 1995 169d
FST CATH-UD, CATHETER
K950908 · FEN Device, Cystometric,... · Gastroenterology & Urology
Apr 1995 50d
4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION
K945495 · EXY Uroflowmeter · Gastroenterology & Urology
Feb 1995 93d
FST DUAL, DUAL PRESSURE URODYNAMICS MONITOR
K930171 · FEN Device, Cystometric,... · Gastroenterology & Urology
Nov 1993 295d
URO-PRO 2000
K922476 · FAP Cystometric Gas... · Gastroenterology & Urology
Jul 1993 420d
FST COUNCIL TIP FOLEY CATHETER
K922776 · FEN Device, Cystometric,... · Gastroenterology & Urology
Jul 1993 406d
FST CATH UD-DUAL DUAL PRESSURE CATHETER
K926088 · FEN Device, Cystometric,... · Gastroenterology & Urology
Jun 1993 198d
FST CATH-UD CATHETER, MODIFICATION
K913113 · FEN Device, Cystometric,... · Gastroenterology & Urology
Oct 1991 96d
FST CATH - UI USRODYNAMIC CATH INTRODUCER SYSTEM
K913721 · FEN Device, Cystometric,... · Gastroenterology & Urology
Oct 1991 49d
FST CATH-UD CATHETER
K905641 · FEN Device, Cystometric,... · Gastroenterology & Urology
Feb 1991 63d
FST DISPOSABLE FIBER OPTIC TRANSDUCER #0100-00
K864000 · DXO Transducer, Pressure,... · Cardiovascular
Jan 1987 94d
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