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510(k) K873031

STARKEY MODEL P1 MODULE by Starkey Laboratories, Inc. — Product Code LRB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 1988
Date Received
August 4, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Face Plate Hearing Aid
Device Class
Class I
Regulation Number
874.3300
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)

Other clearances for product code LRB

  • K974219 — FACEPLATE ASSEMBLY (February 20, 1998)
  • K961593 — INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS (November 7, 1996)
  • K942722 — MODULE PROGRAM (September 6, 1994)
  • K942236 — AUDINA PREWIRES (FACEPLATE HEARING AID SERIES) (June 17, 1994)
  • K935048 — ARTISAN PROGRAMMER & HEARING AID (February 9, 1994)
  • K933038 — GOLD AF MODULE, ITE (August 2, 1993)
  • K933037 — GOLD K AMP, ITE (August 2, 1993)
  • K933044 — SILVER LD MODULE, ITE (August 2, 1993)
  • K933046 — SILVER L MODULE, ITE (August 2, 1993)
  • K933040 — GOLD CD MODULE, ITE (August 2, 1993)