GENERAL PURPOSE COMBINATION PH ELECTRODE— 510(k) K871921

Name: FDA 510(k) clearance K871921
Creator: U.S. Food and Drug Administration
Published: 1987-10-20

Substantially Equivalent

Chemfet Corp.

FDA 510(k) clearance K871921 for GENERAL PURPOSE COMBINATION PH ELECTRODE, Substantially Equivalent on 1987-10-20. Applicant: Chemfet Corp.. Device class: 1.

Clearance details

Applicant: Chemfet Corp.
Product code: Code FFT
Device class: Class 1
Regulation: 21 CFR 876.1400
Advisory panel: Gastroenterology, Urology
Date received: 1987-05-18
Decision date: 1987-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellevue, WA, US

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.