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FDA 510(k)

INTRA-ORAL ARTIFICIAL LARYNX

K-Number: K831127 · 1983-07-28

ApplicantXomed, Inc.
Decision Date1983-07-28
Product CodeESE
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

INTRA-ORAL ARTIFICIAL LARYNX is the device name listed in this FDA 510(k) record. The listed applicant is Xomed, Inc.. It received FDA 510(k) clearance on 1983-07-28 under 510(k) number K831127. The device is classified under product code ESE. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRA-ORAL ARTIFICIAL LARYNX?

INTRA-ORAL ARTIFICIAL LARYNX is a medical device that received FDA 510(k) clearance on 1983-07-28. The listed applicant is Xomed, Inc.. The 510(k) number is K831127.

When did INTRA-ORAL ARTIFICIAL LARYNX receive FDA 510(k) clearance?

INTRA-ORAL ARTIFICIAL LARYNX received FDA 510(k) clearance on 1983-07-28, under 510(k) number K831127.

Who is the listed applicant for INTRA-ORAL ARTIFICIAL LARYNX?

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

What is the FDA product code for INTRA-ORAL ARTIFICIAL LARYNX?

The FDA product code for INTRA-ORAL ARTIFICIAL LARYNX is ESE.

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Other records listing Xomed, Inc. as applicant

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.

K002395MODEL 30 CLASSIC PNEUMATONOMETERK002987REDTRONIC XOMED MONOPOLAR ENERGIZED BLADEK002828XPS NITRO SYSTEMK002897TITANIUM MIDDLE EAR PROSTHESESK993653MICRO-FRANCE TROCARS AND ACCESSORIESK001148MEROGEL OTOLOGIC PACK

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Related Devices (Code: ESE)

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.

K934483NU-VOIS BATTERY POWERED ARTIFICIAL LARYNXMountain Precision Mfg. Ltd. Co.K931371DENRICK SPEECH AID (DR-1)Denrick Corp.K923648LECTRO-LARYNXBruce Medical SupplyK914816AMERICAN ARTIFICIAL LARYNXUltravoice, Ltd.K901503ADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER SYSTEMStanton Magnetics, Inc.K860992VOX COMPANIONBloomfield Research and Development, Inc.

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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