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FDA 510(k)

IMAGE PRO URODYNAMICS MEASURING SYST, MODIFICATION

K-Number: K920991 · 1992-04-10

ApplicantBrowne Medical Systems, Inc.
Decision Date1992-04-10
Product CodeFAP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

IMAGE PRO URODYNAMICS MEASURING SYST, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Browne Medical Systems, Inc.. It received FDA 510(k) clearance on 1992-04-10 under 510(k) number K920991. The device is classified under product code FAP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMAGE PRO URODYNAMICS MEASURING SYST, MODIFICATION?

IMAGE PRO URODYNAMICS MEASURING SYST, MODIFICATION is a medical device that received FDA 510(k) clearance on 1992-04-10. The listed applicant is Browne Medical Systems, Inc.. The 510(k) number is K920991.

When did IMAGE PRO URODYNAMICS MEASURING SYST, MODIFICATION receive FDA 510(k) clearance?

IMAGE PRO URODYNAMICS MEASURING SYST, MODIFICATION received FDA 510(k) clearance on 1992-04-10, under 510(k) number K920991.

Who is the listed applicant for IMAGE PRO URODYNAMICS MEASURING SYST, MODIFICATION?

The FDA 510(k) record lists Browne Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMAGE PRO URODYNAMICS MEASURING SYST, MODIFICATION?

The FDA product code for IMAGE PRO URODYNAMICS MEASURING SYST, MODIFICATION is FAP.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Browne Medical Systems, 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.

K920992PROFILE PLUS URODYNAMICS MEASURING SYST, MODIFIEDK921047MODEL 8100 URODYNAMICS MEASURING SYSTEMK910444BROWNE MEDICAL SYSTEMS IMAGEPROK910371URODYNAMIC MEASURING SYSTEMK910217MINIPRO 8100 URODYNAMIC MEASUREING SYSTEMK910285BROWNE MEDICAL SYST.INC STAND-ALONE WATER PUMP

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Related Devices (Code: FAP)

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.

K113771SIGNAL GEAR URETHRAL CATHETER ELECTRODENeurovision Medical Products, Inc.K974775SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGEAirtronic Services, Inc.K963330URODYNAMIC ANALYSIS MODULESynectics Medical, Inc.K962472RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETERRusch Intl.K931175SCHUSTER DISPOSABLE BALLOON PROBESandhill Scientific, Inc.K931179UROLAB SPECTRUMLife-Tech Intl., 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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