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510(k) K981327

INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER by Idem (Int'L Dist. of Electronics For Medicine) — Product Code EWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1998
Date Received
April 13, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Audiometer
Device Class
Class II
Regulation Number
874.1050
Review Panel
EN
Submission Type

Other clearances by Idem (Int'L Dist. of Electronics For Medicine)

  • K991853 — INTERACOUSTICS EP 15 ABR STAND ALONE UNIT (October 25, 1999)
  • K990652 — INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER (May 17, 1999)
  • K990585 — INTERACOUSTICS AT22T AUTOMATIC IMPEDANCE AUDIOMETER (May 17, 1999)
  • K983832 — INTERACOUSTICS MODEL MT 10, HANDHELD IMPEDANCE AUDIOMETER (January 25, 1999)
  • K982249 — INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER (August 7, 1998)

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