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510(k) K960567

HF MEGA EAR by Maxi-Aids, Inc. — Product Code EPF

K960567 is an FDA 510(k) premarket notification submitted by Maxi-Aids, Inc. for the device "HF MEGA EAR". The FDA issued a decision of Substantially Equivalent on October 16, 1996. The device falls under product code EPF (Hearing Aid, Group And Auditory Trainer), a Class II device regulated under 21 CFR 874.3320. Maxi-Aids, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1996
Date Received
February 9, 1996
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 Maxi-Aids, Inc.

  • K041778 — REIZEN TALKING BLOOD PRESSURE MONITOR, MODEL #SF860T (August 31, 2004)

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)
  • K970665 — WILLIAMS SOUND, PERSONAL FM, HEARING HELPER (May 2, 1997)
  • 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