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FDA 510(k)

SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE

K-Number: K974775 · 1998-02-19

ApplicantAirtronic Services, Inc.
Decision Date1998-02-19
Product CodeFAP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE is the device name listed in this FDA 510(k) record. The listed applicant is Airtronic Services, Inc.. It received FDA 510(k) clearance on 1998-02-19 under 510(k) number K974775. 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 SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE?

SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE is a medical device that received FDA 510(k) clearance on 1998-02-19. The listed applicant is Airtronic Services, Inc.. The 510(k) number is K974775.

When did SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE receive FDA 510(k) clearance?

SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE received FDA 510(k) clearance on 1998-02-19, under 510(k) number K974775.

Who is the listed applicant for SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE?

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

What is the FDA product code for SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE?

The FDA product code for SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE is FAP.

Related Clinical Trials

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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.K963330URODYNAMIC ANALYSIS MODULESynectics Medical, Inc.K962472RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETERRusch Intl.K931175SCHUSTER DISPOSABLE BALLOON PROBESandhill Scientific, Inc.K931179UROLAB SPECTRUMLife-Tech Intl., Inc.K922476URO-PRO 2000Fiberoptic Sensor Technlogies, Inc.

Official Source

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