Home / 510(k) Clearances / K811790

510(k) K811790

OCTOTOXIC SCREENER by Western Advanced Technology, Inc. — Product Code ETS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 1981
Date Received
June 24, 1981
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 Western Advanced Technology, Inc.

  • K822411 — SYSTEM 80 FACEPLATE-IN-THE-EAR #F1 (July 12, 1983)
  • K813557 — AUDITORY STIMULATOR (January 19, 1982)
  • K812138 — TENS DEVICE (August 20, 1981)
  • K811772 — AUDITORY LOCALIZER (July 15, 1981)
  • K802324 — E1 SERIES HEARING AID (October 10, 1980)

Other clearances for product code ETS

  • K813557 — AUDITORY STIMULATOR (January 19, 1982)
  • K811772 — AUDITORY LOCALIZER (July 15, 1981)
  • K790064 — TINNITUS DEVICES (February 16, 1979)
  • K771188 — REVERSING CLICK GENERATOR RCG6 (July 14, 1977)