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510(k) K970665

WILLIAMS SOUND, PERSONAL FM, HEARING HELPER by Williams Sound, LLC — Product Code EPF

K970665 is an FDA 510(k) premarket notification submitted by Williams Sound, LLC for the device "WILLIAMS SOUND, PERSONAL FM, HEARING HELPER". The FDA issued a decision of Substantially Equivalent on May 2, 1997. The device falls under product code EPF (Hearing Aid, Group And Auditory Trainer), a Class II device regulated under 21 CFR 874.3320. Williams Sound, LLC has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1997
Date Received
February 21, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hearing Aid, Group And Auditory Trainer
Device Class
Class II
Regulation Number
874.3320
Review Panel
EN
Submission Type

Other clearances by Williams Sound, LLC

  • K970687 — WILLIAMS SOUND, PERSONAL FM, HEARING HELPER (May 2, 1997)
  • K970974 — WILLIAMS SOUND, PERSONAL FM SYSTEM, HEARING HELPER (May 2, 1997)
  • K954748 — POCKETALKER PRO (November 22, 1995)

Other clearances for product code EPF

  • K133352 — HYPERSOUND AUDIO SYSTEM (HSS) (February 12, 2014)
  • K982683 — TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION (October 6, 1998)
  • K974658 — INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIV (February 25, 1998)
  • K974287 — FM RECEIVER - AUDITORY TRAINER (February 10, 1998)
  • K970687 — WILLIAMS SOUND, PERSONAL FM, HEARING HELPER (May 2, 1997)
  • K960567 — HF MEGA EAR (October 16, 1996)
  • K950730 — GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM) (June 30, 1995)
  • K941768 — PHONAK MICROVOX RESONAL FM SYSTEM (June 24, 1994)
  • K940313 — PHONIC EAR (March 22, 1994)
  • K923234 — PE 400IR, PE 400T, PE 400E (September 29, 1992)

FDA data resources