Home / 510(k) Clearances / K061459

510(k) K061459

TRANQUIL TRI-BTE by General Hearing Instruments, Inc. — Product Code KLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2006
Date Received
May 26, 2006
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 General Hearing Instruments, Inc.

  • K974751 — TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC (March 6, 1998)
  • K971399 — AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC (June 13, 1997)
  • K943144 — AURIS CIC (July 20, 1994)
  • K850123 — IN-TH-EAR HEARING AID (March 21, 1985)

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)
  • 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)