DeviceClearance

HORTMANN AMDIS-OAE OAE ANALYZER— 510(k) K980505

Substantially Equivalent

Hortmann AG

FDA 510(k) clearance K980505 for HORTMANN AMDIS-OAE OAE ANALYZER, Substantially Equivalent on 1998-04-07. Applicant: Hortmann AG.

Clearance details

Applicant
Hortmann AG
Product code
Code EWO
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Dripping Springs, TX, 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.