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510(k) K790064

TINNITUS DEVICES by Vicon Instrument Co. — Product Code ETS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1979
Date Received
January 15, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, Electronic Noise (For Audiometric Testing)
Device Class
Class II
Regulation Number
874.1120
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)
  • K771769 — TINNITUS MASKERS, MODELS S564&S574 (January 3, 1978)
  • 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 ETS

  • K813557 — AUDITORY STIMULATOR (January 19, 1982)
  • K811790 — OCTOTOXIC SCREENER (July 15, 1981)
  • K811772 — AUDITORY LOCALIZER (July 15, 1981)
  • K771188 — REVERSING CLICK GENERATOR RCG6 (July 14, 1977)