BIOMETER AUDIOMETER— 510(k) K883505

Substantially Equivalent

Micro Audiometrics Corp.

FDA 510(k) clearance K883505 for BIOMETER AUDIOMETER, Substantially Equivalent on 1989-08-21. Applicant: Micro Audiometrics Corp..

Clearance details

Applicant: Micro Audiometrics Corp.
Product code: Code EWO
Advisory panel: Ear, Nose, Throat
Date received: 1988-08-17
Decision date: 1989-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port Orange, FL, US

Download summary PDF View on FDA.gov ↗

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.