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510(k) K771769

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

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)

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