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510(k) K943460

PORTAREM 2000 by Starkey Laboratories, Inc. — Product Code ETW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 1994
Date Received
July 18, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Hearing Aid / Earphone And Analysis Systems
Device Class
Class II
Regulation Number
874.3310
Review Panel
EN
Submission Type

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  • K964340 — PORTAREM-3000, PFS-6000 (January 10, 1997)
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  • 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)

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