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510(k) K904755

ACOUSTIQ LISTENING DEVICE by Krueger Laboratories — Product Code LZI

K904755 is an FDA 510(k) premarket notification submitted by Krueger Laboratories for the device "ACOUSTIQ LISTENING DEVICE". The FDA issued a decision of Substantially Equivalent on January 29, 1991. The device falls under product code LZI (Device, Assistive Listening), a Class II device regulated under 21 CFR 874.3320.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 1991
Date Received
October 19, 1990
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 for product code LZI

  • K043090 — EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS (December 23, 2004)
  • K970974 — WILLIAMS SOUND, PERSONAL FM SYSTEM, HEARING HELPER (May 2, 1997)
  • 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)

FDA data resources