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510(k) K970974

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

K970974 is an FDA 510(k) premarket notification submitted by Williams Sound, LLC for the device "WILLIAMS SOUND, PERSONAL FM SYSTEM, HEARING HELPER". The FDA issued a decision of Substantially Equivalent on May 2, 1997. The device falls under product code LZI (Device, Assistive Listening), 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
March 17, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Assistive Listening
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)
  • K970665 — WILLIAMS SOUND, PERSONAL FM, HEARING HELPER (May 2, 1997)
  • K954748 — POCKETALKER PRO (November 22, 1995)

Other clearances for product code LZI

  • K043090 — EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS (December 23, 2004)
  • K970340 — AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER (March 26, 1997)
  • K954748 — POCKETALKER PRO (November 22, 1995)
  • K952057 — LISTENAIDER II (June 21, 1995)
  • K934805 — HEARIT (February 7, 1994)
  • K904755 — ACOUSTIQ LISTENING DEVICE (January 29, 1991)

FDA data resources