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FDA 510(k)

NU-VOIS BATTERY POWERED ARTIFICIAL LARYNX

K-Number: K934483 · 1994-03-16

ApplicantMountain Precision Mfg. Ltd. Co.
Decision Date1994-03-16
Product CodeESE
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

NU-VOIS BATTERY POWERED ARTIFICIAL LARYNX is the device name listed in this FDA 510(k) record. The listed applicant is Mountain Precision Mfg. Ltd. Co.. It received FDA 510(k) clearance on 1994-03-16 under 510(k) number K934483. 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 NU-VOIS BATTERY POWERED ARTIFICIAL LARYNX?

NU-VOIS BATTERY POWERED ARTIFICIAL LARYNX is a medical device that received FDA 510(k) clearance on 1994-03-16. The listed applicant is Mountain Precision Mfg. Ltd. Co.. The 510(k) number is K934483.

When did NU-VOIS BATTERY POWERED ARTIFICIAL LARYNX receive FDA 510(k) clearance?

NU-VOIS BATTERY POWERED ARTIFICIAL LARYNX received FDA 510(k) clearance on 1994-03-16, under 510(k) number K934483.

Who is the listed applicant for NU-VOIS BATTERY POWERED ARTIFICIAL LARYNX?

The FDA 510(k) record lists Mountain Precision Mfg. Ltd. Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NU-VOIS BATTERY POWERED ARTIFICIAL LARYNX?

The FDA product code for NU-VOIS BATTERY POWERED 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.

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.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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