Cleared Traditional

SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO

K924383 · Synectics-Dantec · Gastroenterology & Urology
Jun 1993
Decision
297d
Days
Class 2
Risk

About This 510(k) Submission

K924383 is an FDA 510(k) clearance for the SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO, a Cystometric Gas (carbon-dioxide) On Hydraulic Device (Class II — Special Controls, product code FAP), submitted by Synectics-Dantec (Irving, US). The FDA issued a Cleared decision on June 18, 1993, 297 days after receiving the submission on August 25, 1992. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1620.

Submission Details

510(k) Number K924383 FDA.gov
FDA Decision Cleared SESE
Date Received August 25, 1992
Decision Date June 18, 1993
Days to Decision 297 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

Product Code FAP — Cystometric Gas (carbon-dioxide) On Hydraulic Device
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1620

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