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FDA 510(k)

AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER

K-Number: K970340 · 1997-03-26

ApplicantBellab
Decision Date1997-03-26
Product CodeLZI
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER is the device name listed in this FDA 510(k) record. The listed applicant is Bellab. It received FDA 510(k) clearance on 1997-03-26 under 510(k) number K970340. The device is classified under product code LZI. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER?

AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER is a medical device that received FDA 510(k) clearance on 1997-03-26. The listed applicant is Bellab. The 510(k) number is K970340.

When did AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER receive FDA 510(k) clearance?

AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER received FDA 510(k) clearance on 1997-03-26, under 510(k) number K970340.

Who is the listed applicant for AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER?

The FDA 510(k) record lists Bellab as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER?

The FDA product code for AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER is LZI.

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Related Devices (Code: LZI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K043090EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMSPhonic Ear, Inc.K970974WILLIAMS SOUND, PERSONAL FM SYSTEM, HEARING HELPERWilliams Sound, LLCK954748POCKETALKER PROWilliams Sound, LLCK952057LISTENAIDER IINational Hearing Aid Dist., Inc.K934805HEARITJe Liss & Co., Inc.K904755ACOUSTIQ LISTENING DEVICEKrueger Laboratories

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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