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510(k) K140845

LEVO TINNITUS MASKING SOFTWARE DEVICE by Otoharmonics Corp — Product Code KLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2014
Date Received
April 2, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Masker, Tinnitus
Device Class
Class II
Regulation Number
874.3400
Review Panel
EN
Submission Type

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