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510(k) K030180

CRESCENT TINNITUS RETAINING SOUND GENERATOR by Starkey Laboratories, Inc. — Product Code KLW

K030180 is an FDA 510(k) premarket notification submitted by Starkey Laboratories, Inc. for the device "CRESCENT TINNITUS RETAINING SOUND GENERATOR". The FDA issued a decision of Substantially Equivalent on September 17, 2003. The device falls under product code KLW (Masker, Tinnitus), a Class II device regulated under 21 CFR 874.3400. Starkey Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2003
Date Received
January 17, 2003
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

Other clearances by Starkey Laboratories, Inc.

  • K201370 — Multiflex Tinnitus Technology (June 19, 2020)
  • K122876 — MULTIFLEX TINNITUS TECHNOLOGY (October 31, 2012)
  • 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)
  • K963995 — STARKEY MA-3 AIR CONDUCTION COMBINATION HEARING AID/TINNITUS MASKER (November 26, 1996)
  • K963838 — STARKEY TM AIR CONDUCTION TINNITUS MASKER (November 26, 1996)

Other clearances for product code KLW

  • K260614 — Tinnitus Therapy (June 10, 2026)
  • 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)
  • 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)

FDA data resources