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FDA 510(k)

ACOUSTIQ LISTENING DEVICE

K-Number: K904755 · 1991-01-29

ApplicantKrueger Laboratories
Decision Date1991-01-29
Product CodeLZI
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ACOUSTIQ LISTENING DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Krueger Laboratories. It received FDA 510(k) clearance on 1991-01-29 under 510(k) number K904755. 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 ACOUSTIQ LISTENING DEVICE?

ACOUSTIQ LISTENING DEVICE is a medical device that received FDA 510(k) clearance on 1991-01-29. The listed applicant is Krueger Laboratories. The 510(k) number is K904755.

When did ACOUSTIQ LISTENING DEVICE receive FDA 510(k) clearance?

ACOUSTIQ LISTENING DEVICE received FDA 510(k) clearance on 1991-01-29, under 510(k) number K904755.

Who is the listed applicant for ACOUSTIQ LISTENING DEVICE?

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

What is the FDA product code for ACOUSTIQ LISTENING DEVICE?

The FDA product code for ACOUSTIQ LISTENING DEVICE is LZI.

Related Clinical Trials

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.

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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, LLCK970340AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIERBellabK954748POCKETALKER PROWilliams Sound, LLCK952057LISTENAIDER IINational Hearing Aid Dist., Inc.K934805HEARITJe Liss & Co., Inc.

Official Source

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

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