SYNECTICS PH & PRESSURE ESOPHAGEAL MONIT— 510(k) K842690

Name: FDA 510(k) clearance K842690
Creator: U.S. Food and Drug Administration
Published: 1984-11-08

Substantially Equivalent

Synectics AB

FDA 510(k) clearance K842690 for SYNECTICS PH & PRESSURE ESOPHAGEAL MONIT, Substantially Equivalent on 1984-11-08. Applicant: Synectics AB. Device class: 1.

Clearance details

Applicant: Synectics AB
Product code: Code FFT
Device class: Class 1
Regulation: 21 CFR 876.1400
Advisory panel: Gastroenterology, Urology
Date received: 1984-07-10
Decision date: 1984-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sweden, SE

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FFT

product code FFT

Injury: 595
Malfunction: 2,175
Other: 1
Total: 2,771

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.