FDA 510(k) Premarket Notification K914799: PREMIER K-AMP

Submission Details & Decision

Normalized public record details for 510(k) notification K914799.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K914799

Applicant / Sponsor

Electone, Inc.

Device Name

PREMIER K-AMP

Product Code

ESD

Decision Date

1992-02-18

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Ear, Nose, Throat (EN)

Clearance Type

Traditional

Third Party Flag

Date Received

1991-10-23

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