Cleared Traditional

MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION

K913817 · Synectics-Dantec · Gastroenterology & Urology
Jun 1992
Decision
290d
Days
Class 1
Risk

About This 510(k) Submission

K913817 is an FDA 510(k) clearance for the MONOCRYSTANT PH-REFERENCE CATHETER, MODIFICATION, a Electrode, Ph, Stomach (Class I — General Controls, product code FFT), submitted by Synectics-Dantec (Sweden, SE). The FDA issued a Cleared decision on June 11, 1992, 290 days after receiving the submission on August 26, 1991. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1400.

Submission Details

510(k) Number K913817 FDA.gov
FDA Decision Cleared SESE
Date Received August 26, 1991
Decision Date June 11, 1992
Days to Decision 290 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

Product Code FFT — Electrode, Ph, Stomach
Device Class Class I — General Controls
CFR Regulation 21 CFR 876.1400

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