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FDA 510(k)

DENRICK SPEECH AID (DR-1)

K-Number: K931371 · 1993-08-25

ApplicantDenrick Corp.
Decision Date1993-08-25
Product CodeESE
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

DENRICK SPEECH AID (DR-1) is the device name listed in this FDA 510(k) record. The listed applicant is Denrick Corp.. It received FDA 510(k) clearance on 1993-08-25 under 510(k) number K931371. 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 DENRICK SPEECH AID (DR-1)?

DENRICK SPEECH AID (DR-1) is a medical device that received FDA 510(k) clearance on 1993-08-25. The listed applicant is Denrick Corp.. The 510(k) number is K931371.

When did DENRICK SPEECH AID (DR-1) receive FDA 510(k) clearance?

DENRICK SPEECH AID (DR-1) received FDA 510(k) clearance on 1993-08-25, under 510(k) number K931371.

Who is the listed applicant for DENRICK SPEECH AID (DR-1)?

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

What is the FDA product code for DENRICK SPEECH AID (DR-1)?

The FDA product code for DENRICK SPEECH AID (DR-1) 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.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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