INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, IT— 510(k) K974658

Name: FDA 510(k) clearance K974658
Creator: U.S. Food and Drug Administration
Published: 1998-02-25

Substantially Equivalent

Phonic Ear, Inc.

FDA 510(k) clearance K974658 for INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, IT, Substantially Equivalent on 1998-02-25. Applicant: Phonic Ear, Inc.. Device class: 2.

Clearance details

Applicant: Phonic Ear, Inc.
Product code: Code EPF
Device class: Class 2
Regulation: 21 CFR 874.3320
Advisory panel: Ear, Nose, Throat
Date received: 1997-12-15
Decision date: 1998-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Petaluma, CA, US

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