Cleared Traditional

K970340 - AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER
(FDA 510(k) Clearance)

K970340 · Bellab · Ear, Nose, Throat

Mar 1997

Decision

56d

Days

Class 2

Risk

K970340 is an FDA 510(k) clearance for the AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER, a Device, Assistive Listening (Class II — Special Controls, product code LZI), submitted by Bellab (Gothenburg, SE). The FDA issued a Cleared decision on March 26, 1997, 56 days after receiving the submission on January 29, 1997. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3320.

Submission Details

510(k) Number	K970340 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 29, 1997
Decision Date	March 26, 1997
Days to Decision	56 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF