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. Device class: 2.

Clearance details

Applicant
Hortmann AG
Product code
Code EWO
Device class
Class 2
Regulation
21 CFR 874.1050
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 ↗

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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.