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510(k) K952057

LISTENAIDER II by National Hearing Aid Dist., Inc. — Product Code LZI

K952057 is an FDA 510(k) premarket notification submitted by National Hearing Aid Dist., Inc. for the device "LISTENAIDER II". The FDA issued a decision of Substantially Equivalent on June 21, 1995. The device falls under product code LZI (Device, Assistive Listening), a Class II device regulated under 21 CFR 874.3320. National Hearing Aid Dist., Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1995
Date Received
May 2, 1995
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 National Hearing Aid Dist., Inc.

  • K971296 — TONDI, MODELS U-03, U-2M1, U-2M4, KA-01, KA-02, KA-03, KA-03A, KA-04, KA-04A, KA (June 20, 1997)
  • K935458 — AUDIPHON, MODEL H-11 (January 5, 1994)

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)
  • K934805 — HEARIT (February 7, 1994)
  • K904755 — ACOUSTIQ LISTENING DEVICE (January 29, 1991)

FDA data resources