PROPHET— 510(k) K953884

Substantially Equivalent

Qualitone

FDA 510(k) clearance K953884 for PROPHET, Substantially Equivalent on 1995-10-27. Applicant: Qualitone.

Clearance details

Applicant: Qualitone
Product code: Code EWO
Advisory panel: Ear, Nose, Throat
Date received: 1995-08-17
Decision date: 1995-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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Adverse events under product code EWO

product code EWO

Other: 2
Total: 2

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.