SET -502T PH ESOPHAGEAL MICRO SIZE ELECTRODE— 510(k) K850778

Name: FDA 510(k) clearance K850778
Creator: U.S. Food and Drug Administration
Published: 1985-06-13

Substantially Equivalent

Settler Medical Electronics, Inc.

FDA 510(k) clearance K850778 for SET -502T PH ESOPHAGEAL MICRO SIZE ELECTRODE, Substantially Equivalent on 1985-06-13. Applicant: Settler Medical Electronics, Inc.. Device class: 1.

Clearance details

Applicant: Settler Medical Electronics, Inc.
Product code: Code FFT
Device class: Class 1
Regulation: 21 CFR 876.1400
Advisory panel: Gastroenterology, Urology
Date received: 1985-02-26
Decision date: 1985-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winnipeg, CA

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.