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FDA 510(k)

4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION

K-Number: K945495 · 1995-02-09

ApplicantFiberoptic Sensor Technlogies, Inc.
Decision Date1995-02-09
Product CodeEXY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION is the device name listed in this FDA 510(k) record. The listed applicant is Fiberoptic Sensor Technlogies, Inc.. It received FDA 510(k) clearance on 1995-02-09 under 510(k) number K945495. The device is classified under product code EXY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION?

4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION is a medical device that received FDA 510(k) clearance on 1995-02-09. The listed applicant is Fiberoptic Sensor Technlogies, Inc.. The 510(k) number is K945495.

When did 4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION receive FDA 510(k) clearance?

4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION received FDA 510(k) clearance on 1995-02-09, under 510(k) number K945495.

Who is the listed applicant for 4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION?

The FDA 510(k) record lists Fiberoptic Sensor Technlogies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION?

The FDA product code for 4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION is EXY.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Fiberoptic Sensor Technlogies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K945753FST FIBEROPTIC PRESSURE CONVERTERK950908FST CATH-UD, CATHETERK930171FST DUAL, DUAL PRESSURE URODYNAMICS MONITORK922476URO-PRO 2000K922776FST COUNCIL TIP FOLEY CATHETERK926088FST CATH UD-DUAL DUAL PRESSURE CATHETER

View all 11 devices →

Related Devices (Code: EXY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K022721UROPOWERW.O.M. World of Medicine AGK971913GR100F URINE FLOWMETERAlbyn Medical , Ltd.K953999DANTEC DA CAPODantec Medical, Inc.K951442FLOLABSynectics Medical, Inc.K944972URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRYMyo/Kinetic Systems, Inc.K941105UORCAP,MODEL NUMBER UDS-UCAPLaborie Medical Tech, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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