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510(k) K193303

Tinnitus Sound Generator Module by GN Hearing A/S — Product Code KLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2020
Date Received
November 29, 2019
Clearance Type
Special
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 by GN Hearing A/S

  • K213424 — Jabra Enhance Plus (January 19, 2022)
  • K180495 — Tinnitus Sound Generator Module (November 30, 2018)
  • K181586 — Tinnitus Sound Generator Module (July 13, 2018)

Other clearances for product code KLW

  • K233435 — Peace N Quiet (0.7.0) (February 27, 2024)
  • 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)
  • K180495 — Tinnitus Sound Generator Module (November 30, 2018)
  • K181586 — Tinnitus Sound Generator Module (July 13, 2018)
  • K171243 — audifon Tinnitus-Module (October 19, 2017)
  • K163094 — TinniLogic Mobile Tinnitus Management Device (May 17, 2017)
  • K161562 — Sound Options Tinnitus Treatment (September 28, 2016)