GSI 65 COMPUTERIZED AUDIOMETER— 510(k) K951759

Substantially Equivalent

Grason-Stadler, Inc.

FDA 510(k) clearance K951759 for GSI 65 COMPUTERIZED AUDIOMETER, Substantially Equivalent on 1995-07-06. Applicant: Grason-Stadler, Inc..

Clearance details

Applicant: Grason-Stadler, Inc.
Product code: Code EWO
Advisory panel: Ear, Nose, Throat
Date received: 1995-04-17
Decision date: 1995-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milford, NH, 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.