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510(k) K771769

TINNITUS MASKERS, MODELS S564&S574 by Vicon Instrument Co. — Product Code KLW

K771769 is an FDA 510(k) premarket notification submitted by Vicon Instrument Co. for the device "TINNITUS MASKERS, MODELS S564&S574". The FDA issued a decision of Substantially Equivalent on January 3, 1978. The device falls under product code KLW (Masker, Tinnitus), a Class II device regulated under 21 CFR 874.3400. Vicon Instrument Co. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1978
Date Received
September 19, 1977
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 Vicon Instrument Co.

  • K811751 — FINETONE MODEL VI HEARING AID (July 15, 1981)
  • K790878 — SCREENING AUDIOMETER, HIGH FREQUENCY (August 3, 1979)
  • K790064 — TINNITUS DEVICES (February 16, 1979)
  • K771762 — MODULAR HEARING DEVICE, MODEL S291 (October 4, 1977)
  • K770938 — TINNITUS AID, MODEL S244 (June 28, 1977)
  • K761216 — HEARING AIDS (MODEL E-552 S-712) (December 16, 1976)
  • K760215 — HEARING AID, S-522 FM (July 21, 1976)

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