Williams Sound, Personal FM, Hearing Helper

FDA 510(k) K970665 · Williams Sound, LLC

Substantially Equivalent

510(k) numberK970665

Submission

Device name
Williams Sound, Personal FM, Hearing Helper
Applicant
Williams Sound, LLC
Eden Prairie, MN, US
Received
February 21, 1997
Decision date
May 2, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
EPF – Hearing Aid, Group And Auditory Trainer
Device class
Class II (moderate risk)
Regulation
21 CFR 874.3320
Specialty
Ear, Nose, Throat

Other 510(k)s with product code EPF

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K133352Hypersound Audio System (HSS)EPF · Traditional Hypersound Health, Inc.02/12/2014SE
K982683Telex Select 1-40 with Adaptive CompressionEPF · Traditional Telex Communications, Inc.10/06/1998SE
K974658Infrared Group Amplification System, Infrared Emitter, Infrared Body Worn Receiver…EPF · Traditional Phonic Ear, Inc.02/25/1998SE
K974287FM Receiver - Auditory TrainerEPF · Traditional Phonic Ear, Inc.02/10/1998SE
K970687Williams Sound, Personal FM, Hearing HelperEPF · Traditional Williams Sound, LLC05/02/1997SE
K960567HF Mega EarEPF · Traditional Maxi-Aids, Inc.10/16/1996SE
K950730Group Auditory Trainer (Group Amplification System)EPF · Traditional Phonic Ear, Inc.06/30/1995SE
K941768Phonak Microvox Resonal FM SystemEPF · Traditional Phonak, Inc.06/24/1994SE
K940313Phonic EarEPF · Traditional Phonic Ear, Inc.03/22/1994SE
K923234Pe 400IR, Pe 400T, Pe 400EEPF · Traditional Phonic Ear, Inc.09/29/1992SE

More from Phonic Ear, Inc.

510(k)DeviceDecision
K970974Williams Sound, Personal FM System, Hearing HelperLZI · Traditional 05/02/1997SE
K970687Williams Sound, Personal FM, Hearing HelperEPF · Traditional 05/02/1997SE
K954748Pocketalker ProLZI · Traditional 11/22/1995SE

Questions and answers

When was Williams Sound, Personal FM, Hearing Helper cleared by the FDA?

Williams Sound, Personal FM, Hearing Helper (K970665) received a 510(k) decision of Substantially Equivalent on May 2, 1997, 70 days after the submission was received.

What is the product code of K970665?

The FDA product code is EPF – Hearing Aid, Group And Auditory Trainer, a Class II (moderate risk) device regulated under 21 CFR 874.3320.