MODEL#1550 MARSONA(R) TINNITUS MASKER

K940567 · Marpac, Inc. · KLW · Jul 6, 1994 · Ear, Nose, Throat

Device Facts

Record IDK940567
Device NameMODEL#1550 MARSONA(R) TINNITUS MASKER
ApplicantMarpac, Inc.
Product CodeKLW · Ear, Nose, Throat
Decision DateJul 6, 1994
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 874.3400
Device ClassClass 2

Regulatory Classification

Identification

A tinnitus masker is an electronic device intended to generate noise of sufficient intensity and bandwidth to mask ringing in the ears or internal head noises. Because the device is able to mask internal noises, it is also used as an aid in hearing external noises and speech.

Special Controls

The special control for this device is patient labeling regarding:(1) Hearing health care professional diagnosis, fitting of the device, and followup care, (2) Risks, (3) Benefits, (4) Warnings for safe use, and (5) Specifications.

Innolitics

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