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510(k) K171243

audifon Tinnitus-Module by Audiofon USA, Inc. — Product Code KLW

K171243 is an FDA 510(k) premarket notification submitted by Audiofon USA, Inc. for the device "audifon Tinnitus-Module". The FDA issued a decision of Substantially Equivalent on October 19, 2017. The device falls under product code KLW (Masker, Tinnitus), a Class II device regulated under 21 CFR 874.3400.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2017
Date Received
April 28, 2017
Clearance Type
Abbreviated
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

Other clearances for product code KLW

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  • K223694 — Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042) (June 30, 2023)
  • K221168 — Tinnitogram Signal Generator (February 1, 2023)
  • K221125 — SilentCloud (January 4, 2023)
  • K201370 — Multiflex Tinnitus Technology (June 19, 2020)
  • K193303 — Tinnitus Sound Generator Module (February 20, 2020)
  • K180495 — Tinnitus Sound Generator Module (November 30, 2018)
  • K181586 — Tinnitus Sound Generator Module (July 13, 2018)
  • K163094 — TinniLogic Mobile Tinnitus Management Device (May 17, 2017)

FDA data resources