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510(k) K233435

Peace N Quiet (0.7.0) by Pnq Health — Product Code KLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2024
Date Received
October 13, 2023
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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  • K171243 — audifon Tinnitus-Module (October 19, 2017)
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  • K161562 — Sound Options Tinnitus Treatment (September 28, 2016)