FDA 510(k) Premarket Notification K840825: SERIES MR IN-THE-EAR CUSTOM HEARING AID

Submission Details & Decision

Normalized public record details for 510(k) notification K840825.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K840825

Applicant / Sponsor

Maico Hearing Instruments, Inc.

Device Name

SERIES MR IN-THE-EAR CUSTOM HEARING AID

Product Code

ESD

Decision Date

1984-03-30

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Ear, Nose, Throat (EN)

Clearance Type

Traditional

Third Party Flag

Date Received

1984-02-24

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