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510(k) K964340

PORTAREM-3000, PFS-6000 by Starkey Laboratories, Inc. — Product Code EWO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1997
Date Received
October 31, 1996
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 Starkey Laboratories, Inc.

  • K201370 — Multiflex Tinnitus Technology (June 19, 2020)
  • K122876 — MULTIFLEX TINNITUS TECHNOLOGY (October 31, 2012)
  • K030180 — CRESCENT TINNITUS RETAINING SOUND GENERATOR (September 17, 2003)
  • K970952 — PRECISE IMPRESSION KIT (May 2, 1997)
  • K964245 — PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS (February 4, 1997)
  • K964216 — STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER (December 6, 1996)
  • K964244 — STARKEY CUSTOM SEQUEL PROGRAMMABLE AND K AMP PROGRAMMABLE AIR CONDUCTION HEARING (November 27, 1996)
  • K964214 — STARKEY A-13 SEQUEL PROGRAMMABLE, A-13 K-AMP PROGRAMMABLE AIR CONDUCTION HEARING (November 27, 1996)
  • K963838 — STARKEY TM AIR CONDUCTION TINNITUS MASKER (November 26, 1996)
  • K963995 — STARKEY MA-3 AIR CONDUCTION COMBINATION HEARING AID/TINNITUS MASKER (November 26, 1996)

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