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510(k) K971080

MAICO MA52 by Bernafon-Maico, Inc. — Product Code EWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1997
Date Received
March 25, 1997
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)
  • K974069 — OPUS 2 - CANAL SERIES (ITC) (December 15, 1997)
  • K974211 — OPUS 2 - FULL CONCHA SERIES - ITE (December 15, 1997)
  • K974152 — OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC) (December 15, 1997)
  • K973948 — DUALINE 100 BTE (October 28, 1997)
  • K971158 — DUALINE 400 CIC (June 13, 1997)
  • K962275 — MAICO MA25 SERIES II WITH SPEECH (September 5, 1996)

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