MAICO MA800 AUDIOMETER— 510(k) K911368

Clearance details

Applicant

Maico Hearing Instruments, Inc.

Product code

Code EWO

Device class

Class 2

Regulation

21 CFR 874.1050

Advisory panel

Ear, Nose, Throat

Date received

1991-03-28

Decision date

1991-06-26

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Minneapolis, MN, US

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• K946253 — MAICO IN-THE-EAR MODEL RD 2011995-01-30

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 →