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FDA 510(k)

DIAGNOSTIC ULTRASOUND/URO-GYN UDS 2000 SERIES

K-Number: K911091 · 1991-06-10

ApplicantDiagnostic Ultrasound Corp.
Decision Date1991-06-10
Product CodeFAP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DIAGNOSTIC ULTRASOUND/URO-GYN UDS 2000 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Ultrasound Corp.. It received FDA 510(k) clearance on 1991-06-10 under 510(k) number K911091. 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 DIAGNOSTIC ULTRASOUND/URO-GYN UDS 2000 SERIES?

DIAGNOSTIC ULTRASOUND/URO-GYN UDS 2000 SERIES is a medical device that received FDA 510(k) clearance on 1991-06-10. The listed applicant is Diagnostic Ultrasound Corp.. The 510(k) number is K911091.

When did DIAGNOSTIC ULTRASOUND/URO-GYN UDS 2000 SERIES receive FDA 510(k) clearance?

DIAGNOSTIC ULTRASOUND/URO-GYN UDS 2000 SERIES received FDA 510(k) clearance on 1991-06-10, under 510(k) number K911091.

Who is the listed applicant for DIAGNOSTIC ULTRASOUND/URO-GYN UDS 2000 SERIES?

The FDA 510(k) record lists Diagnostic Ultrasound Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIAGNOSTIC ULTRASOUND/URO-GYN UDS 2000 SERIES?

The FDA product code for DIAGNOSTIC ULTRASOUND/URO-GYN UDS 2000 SERIES is FAP.

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Other records listing Diagnostic Ultrasound Corp. 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.

K030763DIAGNOSTIC ULTRASOUND BLADDERMASS BVM 6500 ULTRASOUND SYSTEMK022153BLADDERSCAN BVI 6100K982568BLADDERMANAGER PCI 5000 MODEL 1002K963585BLADDER MANAGER PCI 5000, BLADDERSCAN BVI 5000K955840BLADDERMANAGER PCI 5000 / BLADDERSCAN BVI 5000K955942BLADDERSCAN BVI 5000

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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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