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510(k) K962275

MAICO MA25 SERIES II WITH SPEECH by Bernafon-Maico, Inc. — Product Code EWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1996
Date Received
June 13, 1996
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 Bernafon-Maico, Inc.

  • K982723 — MAICO MA42 (October 28, 1998)
  • K981142 — MAICO MA53 (April 22, 1998)
  • K974211 — OPUS 2 - FULL CONCHA SERIES - ITE (December 15, 1997)
  • K974152 — OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC) (December 15, 1997)
  • K974069 — OPUS 2 - CANAL SERIES (ITC) (December 15, 1997)
  • K973948 — DUALINE 100 BTE (October 28, 1997)
  • K971158 — DUALINE 400 CIC (June 13, 1997)
  • K971080 — MAICO MA52 (June 6, 1997)

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