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FDA 510(k)

LABORIE URODYNAMICS PROCESSOR

K-Number: K920777 · 1992-09-04

ApplicantR. Laborie Surgical , Ltd.
Decision Date1992-09-04
Product CodeFAP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LABORIE URODYNAMICS PROCESSOR is the device name listed in this FDA 510(k) record. The listed applicant is R. Laborie Surgical , Ltd.. It received FDA 510(k) clearance on 1992-09-04 under 510(k) number K920777. 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 LABORIE URODYNAMICS PROCESSOR?

LABORIE URODYNAMICS PROCESSOR is a medical device that received FDA 510(k) clearance on 1992-09-04. The listed applicant is R. Laborie Surgical , Ltd.. The 510(k) number is K920777.

When did LABORIE URODYNAMICS PROCESSOR receive FDA 510(k) clearance?

LABORIE URODYNAMICS PROCESSOR received FDA 510(k) clearance on 1992-09-04, under 510(k) number K920777.

Who is the listed applicant for LABORIE URODYNAMICS PROCESSOR?

The FDA 510(k) record lists R. Laborie Surgical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LABORIE URODYNAMICS PROCESSOR?

The FDA product code for LABORIE URODYNAMICS PROCESSOR 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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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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