Listenaider II

FDA 510(k) K952057 · National Hearing Aid Dist., Inc.

Substantially Equivalent

510(k) numberK952057

Submission

Device name
Listenaider II
Applicant
National Hearing Aid Dist., Inc.
Scarborough, ME, US
Received
May 2, 1995
Decision date
June 21, 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
K954748Pocketalker ProLZI · Traditional Williams Sound, LLC11/22/1995SE
K934805HearitLZI · Traditional Je Liss & Co., Inc.02/07/1994SE
K904755Acoustiq Listening DeviceLZI · Traditional Krueger Laboratories01/29/1991SE

More from Krueger Laboratories

510(k)DeviceDecision
K971296Tondi, Models U-03, U-2M1, U-2M4, KA-01, KA-02, KA-03, KA-03A, KA-04, KA-04A, KA-05ESD · Traditional 06/20/1997SE
K935458Audiphon, Model H-11ESD · Traditional 01/05/1994SE

Questions and answers

When was Listenaider II cleared by the FDA?

Listenaider II (K952057) received a 510(k) decision of Substantially Equivalent on June 21, 1995, 50 days after the submission was received.

What is the product code of K952057?

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