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510(k) K991853

INTERACOUSTICS EP 15 ABR STAND ALONE UNIT by Idem (Int'L Dist. of Electronics For Medicine) — Product Code GWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 1999
Date Received
June 1, 1999
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 Idem (Int'L Dist. of Electronics For Medicine)

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  • K983832 — INTERACOUSTICS MODEL MT 10, HANDHELD IMPEDANCE AUDIOMETER (January 25, 1999)
  • K982249 — INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER (August 7, 1998)
  • K981327 — INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER (May 11, 1998)

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