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510(k) K974235

AMPLAID AM50 by Amplifon S.P.A. — Product Code ETY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1998
Date Received
November 12, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tester, Auditory Impedance
Device Class
Class II
Regulation Number
874.1090
Review Panel
EN
Submission Type

Other clearances by Amplifon S.P.A.

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  • K983915 — AMPLAID A315 AND A319 (January 29, 1999)
  • K983712 — AMPLAID A311 SERIES (January 12, 1999)
  • K971740 — AMPLAID MK12 (March 16, 1998)
  • K972959 — AMPLAID MK22 (February 6, 1998)
  • K972862 — AMPLAID 171S (October 31, 1997)
  • K971747 — AMPLAID 460 (August 5, 1997)

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