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510(k) K983712

AMPLAID A311 SERIES by Amplifon S.P.A. — Product Code EWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1999
Date Received
October 21, 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 Amplifon S.P.A.

  • K992370 — AMPLAID A724 AND A728 (September 20, 1999)
  • K983915 — AMPLAID A315 AND A319 (January 29, 1999)
  • K971740 — AMPLAID MK12 (March 16, 1998)
  • K974235 — AMPLAID AM50 (February 10, 1998)
  • K972959 — AMPLAID MK22 (February 6, 1998)
  • K972862 — AMPLAID 171S (October 31, 1997)
  • K971747 — AMPLAID 460 (August 5, 1997)

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  • K173567 — Sera (February 14, 2018)
  • K172403 — GSI Novus (October 20, 2017)
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  • K151025 — iHearTest (December 29, 2015)