Cleared Traditional

ACOUSTIQ LISTENING DEVICE

K904755 · Krueger Laboratories · Ear, Nose, Throat

Jan 1991

Decision

102d

Days

Class 2

Risk

About This 510(k) Submission

K904755 is an FDA 510(k) clearance for the ACOUSTIQ LISTENING DEVICE, a Device, Assistive Listening (Class II — Special Controls, product code LZI), submitted by Krueger Laboratories (Tempe, US). The FDA issued a Cleared decision on January 29, 1991, 102 days after receiving the submission on October 19, 1990. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3320.

Submission Details

510(k) Number	K904755 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 19, 1990
Decision Date	January 29, 1991
Days to Decision	102 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	—