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FDA 510(k)

AMERICAN ARTIFICIAL LARYNX

K-Number: K914816 · 1993-02-12

ApplicantUltravoice, Ltd.
Decision Date1993-02-12
Product CodeESE
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AMERICAN ARTIFICIAL LARYNX is the device name listed in this FDA 510(k) record. The listed applicant is Ultravoice, Ltd.. It received FDA 510(k) clearance on 1993-02-12 under 510(k) number K914816. 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 AMERICAN ARTIFICIAL LARYNX?

AMERICAN ARTIFICIAL LARYNX is a medical device that received FDA 510(k) clearance on 1993-02-12. The listed applicant is Ultravoice, Ltd.. The 510(k) number is K914816.

When did AMERICAN ARTIFICIAL LARYNX receive FDA 510(k) clearance?

AMERICAN ARTIFICIAL LARYNX received FDA 510(k) clearance on 1993-02-12, under 510(k) number K914816.

Who is the listed applicant for AMERICAN ARTIFICIAL LARYNX?

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

What is the FDA product code for AMERICAN ARTIFICIAL LARYNX?

The FDA product code for AMERICAN ARTIFICIAL LARYNX is ESE.

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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 SupplyK901503ADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER SYSTEMStanton Magnetics, Inc.K860992VOX COMPANIONBloomfield Research and Development, Inc.K860993P.O. VOXBloomfield 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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