DeviceClearance

ACAM 5 AUDIOMETER SYSTEM— 510(k) K103298

Substantially Equivalent

Acousticon GmbH

FDA 510(k) clearance K103298 for ACAM 5 AUDIOMETER SYSTEM, Substantially Equivalent on 2011-04-08. Applicant: Acousticon GmbH.

Clearance details

Applicant
Acousticon GmbH
Product code
Code EWO
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Toms River, NJ, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code EWO

product code EWO
Other
2
Total
2

Source: openFDA MAUDE database, through . 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.