AUTOMATIC SELF-OPERATED SCREENING AUDIOMETER DEVICE (ASAM)— 510(k) K982566

Substantially Equivalent

Bar - Advanced Control Systems , Ltd.

FDA 510(k) clearance K982566 for AUTOMATIC SELF-OPERATED SCREENING AUDIOMETER DEVICE (ASAM), Substantially Equivalent on 1998-10-21. Applicant: Bar - Advanced Control Systems , Ltd..

Clearance details

Applicant: Bar - Advanced Control Systems , Ltd.
Product code: Code EWO
Advisory panel: Ear, Nose, Throat
Date received: 1998-07-23
Decision date: 1998-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ginot, Shomron, IL

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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.