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FDA 510(k)

SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO

K-Number: K924383 · 1993-06-18

ApplicantSynectics-Dantec
Decision Date1993-06-18
Product CodeFAP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO is the device name listed in this FDA 510(k) record. The listed applicant is Synectics-Dantec. It received FDA 510(k) clearance on 1993-06-18 under 510(k) number K924383. 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 SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO?

SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO is a medical device that received FDA 510(k) clearance on 1993-06-18. The listed applicant is Synectics-Dantec. The 510(k) number is K924383.

When did SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO receive FDA 510(k) clearance?

SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO received FDA 510(k) clearance on 1993-06-18, under 510(k) number K924383.

Who is the listed applicant for SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO?

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

What is the FDA product code for SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO?

The FDA product code for SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO is FAP.

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Other records listing Synectics-Dantec 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.

K961346PH ANALYSIS MODULEK925405ZINETICS COMPOSITE SENSOR PROBE W/INTERNAL REF.K924875MICROTRAPPER/MICRODIGITRAPPER, ADD MODIFICATIONSK914793MONOCRYSTANT PH/LES CATHETER, MODIFICATIONK913817MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATIONK914624PH METER, MODIFICATION

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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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