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FDA 510(k)

BIOFEEDBACK SYSTEM FOR SPEECH DISORDERS

K-Number: K942651 · 1995-10-19

ApplicantCasa Futura Technologies
Decision Date1995-10-19
Product CodeKTH
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BIOFEEDBACK SYSTEM FOR SPEECH DISORDERS is the device name listed in this FDA 510(k) record. The listed applicant is Casa Futura Technologies. It received FDA 510(k) clearance on 1995-10-19 under 510(k) number K942651. The device is classified under product code KTH. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOFEEDBACK SYSTEM FOR SPEECH DISORDERS?

BIOFEEDBACK SYSTEM FOR SPEECH DISORDERS is a medical device that received FDA 510(k) clearance on 1995-10-19. The listed applicant is Casa Futura Technologies. The 510(k) number is K942651.

When did BIOFEEDBACK SYSTEM FOR SPEECH DISORDERS receive FDA 510(k) clearance?

BIOFEEDBACK SYSTEM FOR SPEECH DISORDERS received FDA 510(k) clearance on 1995-10-19, under 510(k) number K942651.

Who is the listed applicant for BIOFEEDBACK SYSTEM FOR SPEECH DISORDERS?

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

What is the FDA product code for BIOFEEDBACK SYSTEM FOR SPEECH DISORDERS?

The FDA product code for BIOFEEDBACK SYSTEM FOR SPEECH DISORDERS is KTH.

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Related Devices (Code: KTH)

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.

K962961SUSTAINED PHONATIONSurface Mount Technology, Inc.K871590VOCALTECH VOCAL FEEDBACK DEVICEVocaltech C/O Hogan & HartsonK800445EDINBURGH MASKERFoundation For Fluency, 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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