AUDIOSCAN— 510(k) K926336

Substantially Equivalent

Electrocaine Medical System

FDA 510(k) clearance K926336 for AUDIOSCAN, Substantially Equivalent on 1993-03-04. Applicant: Electrocaine Medical System.

Clearance details

Applicant: Electrocaine Medical System
Product code: Code EWO
Advisory panel: Ear, Nose, Throat
Date received: 1992-12-16
Decision date: 1993-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lancaster, PA, 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.