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510(k) K941768

PHONAK MICROVOX RESONAL FM SYSTEM by Phonak, Inc. — Product Code EPF

K941768 is an FDA 510(k) premarket notification submitted by Phonak, Inc. for the device "PHONAK MICROVOX RESONAL FM SYSTEM". The FDA issued a decision of Substantially Equivalent on June 24, 1994. The device falls under product code EPF (Hearing Aid, Group And Auditory Trainer), a Class II device regulated under 21 CFR 874.3320. Phonak, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1994
Date Received
April 11, 1994
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 Phonak, Inc.

  • K130790 — LYRIC2 (June 27, 2013)
  • K123450 — PHONAK TINNITUS BALANCE (February 11, 2013)
  • K972106 — PHONAK NOVO FORTE E3 (August 15, 1997)
  • K972105 — PHONAK EPICA (August 1, 1997)
  • K972097 — PHONAK MICROZOOM P 2 (July 30, 1997)
  • K964035 — PHONAK MICROLINK, PERSONAL FM RECEIVER (December 4, 1996)
  • K961653 — PHONAK SONA P2 (May 29, 1996)
  • K961622 — PHONAK PICONET2 P2 AZ (May 17, 1996)
  • K953921 — PHONAK 9900 CIC (September 18, 1995)
  • K945439 — PHONAK PICONET 232X-AZ HEARING INSTRUMENT (August 23, 1995)

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)
  • K960567 — HF MEGA EAR (October 16, 1996)
  • K950730 — GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM) (June 30, 1995)
  • K940313 — PHONIC EAR (March 22, 1994)
  • K923234 — PE 400IR, PE 400T, PE 400E (September 29, 1992)

FDA data resources