FDA 510(k) Applications Submitted by Starkey Laboratories, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K201370 05/22/2020 Multiflex Tinnitus Technology Starkey Laboratories, Inc.
K963519 09/03/1996 EUROLINE A-675 SERIS STARKEY LABORATORIES, INC.
K964244 10/24/1996 STARKEY CUSTOM SEQUEL PROGRAMMABLE AND K AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS STARKEY LABORATORIES, INC.
K960494 01/30/1996 EUROLINE A312 SERIES OF BEHIND THE EAR AIR CONDUCTION HEARING AIDS STARKEY LABORATORIES, INC.
K963838 09/24/1996 STARKEY TM AIR CONDUCTION TINNITUS MASKER STARKEY LABORATORIES, INC.
K964340 10/31/1996 PORTAREM-3000, PFS-6000 STARKEY LABORATORIES, INC.
K030180 01/17/2003 CRESCENT TINNITUS RETAINING SOUND GENERATOR STARKEY LABORATORIES, INC.
K970952 03/14/1997 PRECISE IMPRESSION KIT STARKEY LABORATORIES, INC.
K963995 10/04/1996 STARKEY MA-3 AIR CONDUCTION COMBINATION HEARING AID/TINNITUS MASKER STARKEY LABORATORIES, INC.
K964214 10/22/1996 STARKEY A-13 SEQUEL PROGRAMMABLE, A-13 K-AMP PROGRAMMABLE AIR CONDUCTION HEARING AIDS STARKEY LABORATORIES, INC.
K964216 10/22/1996 STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER STARKEY LABORATORIES, INC.
K964245 10/24/1996 PRECISE, TYNMPANETTE, AND XACTO IMPRESSION KITS STARKEY LABORATORIES, INC.


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