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510(k) K201370

Multiflex Tinnitus Technology by Starkey Laboratories, Inc. — Product Code KLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 2020
Date Received
May 22, 2020
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 Starkey Laboratories, Inc.

  • K122876 — MULTIFLEX TINNITUS TECHNOLOGY (October 31, 2012)
  • K030180 — CRESCENT TINNITUS RETAINING SOUND GENERATOR (September 17, 2003)
  • K970952 — PRECISE IMPRESSION KIT (May 2, 1997)
  • K964245 — PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS (February 4, 1997)
  • K964340 — PORTAREM-3000, PFS-6000 (January 10, 1997)
  • K964216 — STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER (December 6, 1996)
  • K964244 — STARKEY CUSTOM SEQUEL PROGRAMMABLE AND K AMP PROGRAMMABLE AIR CONDUCTION HEARING (November 27, 1996)
  • K964214 — STARKEY A-13 SEQUEL PROGRAMMABLE, A-13 K-AMP PROGRAMMABLE AIR CONDUCTION HEARING (November 27, 1996)
  • K963838 — STARKEY TM AIR CONDUCTION TINNITUS MASKER (November 26, 1996)
  • K963995 — STARKEY MA-3 AIR CONDUCTION COMBINATION HEARING AID/TINNITUS MASKER (November 26, 1996)

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)
  • K193303 — Tinnitus Sound Generator Module (February 20, 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)