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FDA 510(k)

UROBEI STRESS INCONTINENCE MONITOR

K-Number: K851483 · 1985-08-07

ApplicantBrowne Medical, Inc.
Decision Date1985-08-07
Product CodeFAP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UROBEI STRESS INCONTINENCE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Browne Medical, Inc.. It received FDA 510(k) clearance on 1985-08-07 under 510(k) number K851483. 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 UROBEI STRESS INCONTINENCE MONITOR?

UROBEI STRESS INCONTINENCE MONITOR is a medical device that received FDA 510(k) clearance on 1985-08-07. The listed applicant is Browne Medical, Inc.. The 510(k) number is K851483.

When did UROBEI STRESS INCONTINENCE MONITOR receive FDA 510(k) clearance?

UROBEI STRESS INCONTINENCE MONITOR received FDA 510(k) clearance on 1985-08-07, under 510(k) number K851483.

Who is the listed applicant for UROBEI STRESS INCONTINENCE MONITOR?

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

What is the FDA product code for UROBEI STRESS INCONTINENCE MONITOR?

The FDA product code for UROBEI STRESS INCONTINENCE MONITOR 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, 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.

K834503PROFILE URODYNAMIC MONITORING SYSK833043UROMETERK830221BEDSIDE N.P.T. 9900 - PRINTER 9800

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

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

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