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510(k) K971747

AMPLAID 460 by Amplifon S.P.A. — Product Code EWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 1997
Date Received
May 12, 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 Amplifon S.P.A.

  • K992370 — AMPLAID A724 AND A728 (September 20, 1999)
  • K983915 — AMPLAID A315 AND A319 (January 29, 1999)
  • K983712 — AMPLAID A311 SERIES (January 12, 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)

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  • K191372 — Lyra (July 15, 2019)
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  • K173567 — Sera (February 14, 2018)
  • K172403 — GSI Novus (October 20, 2017)
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  • K151025 — iHearTest (December 29, 2015)