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510(k) K133352

HYPERSOUND AUDIO SYSTEM (HSS) by Hypersound Health, Inc. — Product Code EPF

K133352 is an FDA 510(k) premarket notification submitted by Hypersound Health, Inc. for the device "HYPERSOUND AUDIO SYSTEM (HSS)". The FDA issued a decision of Substantially Equivalent on February 12, 2014. The device falls under product code EPF (Hearing Aid, Group And Auditory Trainer), a Class II device regulated under 21 CFR 874.3320.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2014
Date Received
October 31, 2013
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 for product code EPF

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