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510(k) K123450

PHONAK TINNITUS BALANCE by Phonak, LLC — Product Code KLW

K123450 is an FDA 510(k) premarket notification submitted by Phonak, LLC for the device "PHONAK TINNITUS BALANCE". The FDA issued a decision of Substantially Equivalent on February 11, 2013. The device falls under product code KLW (Masker, Tinnitus), a Class II device regulated under 21 CFR 874.3400. Phonak, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2013
Date Received
November 9, 2012
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 by Phonak, LLC

  • K130790 — LYRIC2 (June 27, 2013)
  • K972106 — PHONAK NOVO FORTE E3 (August 15, 1997)
  • K972105 — PHONAK EPICA (August 1, 1997)
  • K972097 — PHONAK MICROZOOM P 2 (July 30, 1997)
  • K964035 — PHONAK MICROLINK, PERSONAL FM RECEIVER (December 4, 1996)
  • K961653 — PHONAK SONA P2 (May 29, 1996)
  • K961622 — PHONAK PICONET2 P2 AZ (May 17, 1996)
  • K953921 — PHONAK 9900 CIC (September 18, 1995)
  • K945439 — PHONAK PICONET 232X-AZ HEARING INSTRUMENT (August 23, 1995)
  • K950758 — DYNA 231X (March 21, 1995)

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