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510(k) K790481

MODEL FS1 by Starkey Laboratories, Inc. — Product Code KHL

K790481 is an FDA 510(k) premarket notification submitted by Starkey Laboratories, Inc. for the device "MODEL FS1". The FDA issued a decision of Substantially Equivalent on April 3, 1979. The device falls under product code KHL (Hearing Aid, Master), a Class II device regulated under 21 CFR 874.3330. Starkey Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1979
Date Received
March 8, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hearing Aid, Master
Device Class
Class II
Regulation Number
874.3330
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)
  • K964340 — PORTAREM-3000, PFS-6000 (January 10, 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)

Other clearances for product code KHL

  • K964080 — LORI HEARING AID SIMULATOR (January 8, 1997)
  • K911726 — PROGRAMMABLE AUDITORY COMPARATOR, MODIFICATION (October 23, 1991)
  • K894019 — RESOUND DEMO. BEHIND-THE-EAR HRNG., MODEL DEMO BTE (September 21, 1989)
  • K860171 — VOROBA PROGRAMMABLE AUDITORY COMPARATOR (May 2, 1986)
  • K854126 — CRAIGWELL MASTER HEARING AID MHA (January 16, 1986)
  • K802812 — RIONET HEARING AID (November 26, 1980)

FDA data resources