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FDA 510(k)

MODEL 8100 URODYNAMICS MEASURING SYSTEM

K-Number: K921047 · 1992-04-10

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

Device Summary

MODEL 8100 URODYNAMICS MEASURING SYSTEM 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 K921047. 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 MODEL 8100 URODYNAMICS MEASURING SYSTEM?

MODEL 8100 URODYNAMICS MEASURING SYSTEM 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 K921047.

When did MODEL 8100 URODYNAMICS MEASURING SYSTEM receive FDA 510(k) clearance?

MODEL 8100 URODYNAMICS MEASURING SYSTEM received FDA 510(k) clearance on 1992-04-10, under 510(k) number K921047.

Who is the listed applicant for MODEL 8100 URODYNAMICS MEASURING SYSTEM?

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 MODEL 8100 URODYNAMICS MEASURING SYSTEM?

The FDA product code for MODEL 8100 URODYNAMICS MEASURING SYSTEM 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.

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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, MODIFIEDK920991IMAGE PRO URODYNAMICS MEASURING SYST, MODIFICATIONK910444BROWNE 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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