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FDA 510(k)

UMS-100

K-Number: K853683 · 1986-01-10

ApplicantNarco Bio-Systems
Decision Date1986-01-10
Product CodeFAP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

UMS-100 is the device name listed in this FDA 510(k) record. The listed applicant is Narco Bio-Systems. It received FDA 510(k) clearance on 1986-01-10 under 510(k) number K853683. 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 UMS-100?

UMS-100 is a medical device that received FDA 510(k) clearance on 1986-01-10. The listed applicant is Narco Bio-Systems. The 510(k) number is K853683.

When did UMS-100 receive FDA 510(k) clearance?

UMS-100 received FDA 510(k) clearance on 1986-01-10, under 510(k) number K853683.

Who is the listed applicant for UMS-100?

The FDA 510(k) record lists Narco Bio-Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UMS-100?

The FDA product code for UMS-100 is FAP.

Other records listing Narco Bio-Systems 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.

K833656NARCOTRACE 40 - NT40K832869MOTILITY MEASUREMENT SYS MMS-100K813502NARCO TELECARE ISOFLO PRESSURE MONITORK811376ULTRASONIC QFM SYSTEM 1000K810431NARCO TLECARE MINIATURE PRESSURE DOMEK801544PORTA-FIB LPD

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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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