FDA 510(k) Premarket Notification K912571: PHONAK PHONICA MODEL 312-SC ITE HEARING INSTRUMENT

Submission Details & Decision

Normalized public record details for 510(k) notification K912571.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K912571

Applicant / Sponsor

Phonak, Inc.

Device Name

PHONAK PHONICA MODEL 312-SC ITE HEARING INSTRUMENT

Product Code

ESD

Decision Date

1991-06-26

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Ear, Nose, Throat (EN)

Clearance Type

Traditional

Third Party Flag

Date Received

1991-06-11

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