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FDA 510(k)

SUSTAINED PHONATION

K-Number: K962961 · 1996-09-09

ApplicantSurface Mount Technology, Inc.
Decision Date1996-09-09
Product CodeKTH
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SUSTAINED PHONATION is the device name listed in this FDA 510(k) record. The listed applicant is Surface Mount Technology, Inc.. It received FDA 510(k) clearance on 1996-09-09 under 510(k) number K962961. 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 SUSTAINED PHONATION?

SUSTAINED PHONATION is a medical device that received FDA 510(k) clearance on 1996-09-09. The listed applicant is Surface Mount Technology, Inc.. The 510(k) number is K962961.

When did SUSTAINED PHONATION receive FDA 510(k) clearance?

SUSTAINED PHONATION received FDA 510(k) clearance on 1996-09-09, under 510(k) number K962961.

Who is the listed applicant for SUSTAINED PHONATION?

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

What is the FDA product code for SUSTAINED PHONATION?

The FDA product code for SUSTAINED PHONATION is KTH.

Related Clinical Trials

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Other records listing Surface Mount Technology, 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.

K932714ELECTRONIC GLOVE INTEGRITY MONITOR (EGIM)

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.

K942651BIOFEEDBACK SYSTEM FOR SPEECH DISORDERSCasa Futura TechnologiesK871590VOCALTECH VOCAL FEEDBACK DEVICEVocaltech C/O Hogan & HartsonK800445EDINBURGH MASKERFoundation For Fluency, Inc.

Official Source

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