AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER— 510(k) K970340

Name: FDA 510(k) clearance K970340
Creator: U.S. Food and Drug Administration
Published: 1997-03-26

Substantially Equivalent

Bellab

FDA 510(k) clearance K970340 for AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER, Substantially Equivalent on 1997-03-26. Applicant: Bellab. Device class: 2.

Clearance details

Applicant: Bellab
Product code: Code LZI
Device class: Class 2
Regulation: 21 CFR 874.3320
Advisory panel: Ear, Nose, Throat
Date received: 1997-01-29
Decision date: 1997-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gothenburg, SE

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Data sourced from openFDA. This site is unofficial and independent of the FDA.