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510(k) K870030

THE SCREENER GSI 55 ABR SCREENER by Grason-Stadler, Inc. — Product Code GWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1987
Date Received
January 5, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Auditory, Evoked Response
Device Class
Class II
Regulation Number
882.1900
Review Panel
NE
Submission Type

Other clearances by Grason-Stadler, Inc.

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  • K000097 — GSI 2000 MIDDLE EAR ANALYZER (April 12, 2000)
  • K974237 — GSI 70 AUDIOPATH SCREENER (February 10, 1998)
  • K970324 — GSI SA60 DPOAE SYSTEM (June 6, 1997)
  • K953684 — GSI 61 CLINICAL AUDIOMETER (October 27, 1995)
  • K951759 — GSI 65 COMPUTERIZED AUDIOMETER (July 6, 1995)
  • K902540 — GSI 17 SCREENING AUDIOMETER (July 13, 1990)
  • K890124 — ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER (July 14, 1989)
  • K863353 — MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER) (November 3, 1986)

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