PH ANALYSIS MODULE— 510(k) K961346

Substantially Equivalent

Synectics-Dantec

FDA 510(k) clearance K961346 for PH ANALYSIS MODULE, Substantially Equivalent on 1997-01-29. Applicant: Synectics-Dantec.

Clearance details

Applicant: Synectics-Dantec
Product code: Code FFT
Advisory panel: Gastroenterology, Urology
Date received: 1996-03-15
Decision date: 1997-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sweden, SE

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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.