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510(k) K971740

AMPLAID MK12 by Amplifon S.P.A. — Product Code GWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1998
Date Received
May 12, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Electrical, Evoked Response
Device Class
Class II
Regulation Number
882.1870
Review Panel
NE
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)
  • 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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