Pocketalker Pro

FDA 510(k) K954748 · Williams Sound, LLC

Substantially Equivalent

510(k) numberK954748

Submission

Device name
Pocketalker Pro
Applicant
Williams Sound, LLC
Eden Prairie, MN, US
Received
October 16, 1995
Decision date
November 22, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
LZI – Device, Assistive Listening
Device class
Class II (moderate risk)
Regulation
21 CFR 874.3320
Specialty
Ear, Nose, Throat

Other 510(k)s with product code LZI

510(k)DeviceApplicantDecision
K043090Easylistener 2 FM, Radium FM and Vocalight Infrared Sound Field SystemsLZI · Traditional Phonic Ear, Inc.12/23/2004SE
K970974Williams Sound, Personal FM System, Hearing HelperLZI · Traditional Williams Sound, LLC05/02/1997SE
K970340Air Conduction Assistive Listening Device.Personal AmplifierLZI · Traditional Bellab03/26/1997SE
K952057Listenaider IILZI · Traditional National Hearing Aid Dist., Inc.06/21/1995SE
K934805HearitLZI · Traditional Je Liss & Co., Inc.02/07/1994SE
K904755Acoustiq Listening DeviceLZI · Traditional Krueger Laboratories01/29/1991SE

More from Krueger Laboratories

510(k)DeviceDecision
K970974Williams Sound, Personal FM System, Hearing HelperLZI · Traditional 05/02/1997SE
K970687Williams Sound, Personal FM, Hearing HelperEPF · Traditional 05/02/1997SE
K970665Williams Sound, Personal FM, Hearing HelperEPF · Traditional 05/02/1997SE

Questions and answers

When was Pocketalker Pro cleared by the FDA?

Pocketalker Pro (K954748) received a 510(k) decision of Substantially Equivalent on November 22, 1995, 37 days after the submission was received.

What is the product code of K954748?

The FDA product code is LZI – Device, Assistive Listening, a Class II (moderate risk) device regulated under 21 CFR 874.3320.