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FDA 510(k)

THE VISUAL SPEECH AID

K-Number: K781522 · 1978-11-08

ApplicantExeter Medical Labs, Inc.
Decision Date1978-11-08
Product CodeLFA
DecisionSubstantially Equivalent

Device Summary

THE VISUAL SPEECH AID is the device name listed in this FDA 510(k) record. The listed applicant is Exeter Medical Labs, Inc.. It received FDA 510(k) clearance on 1978-11-08 under 510(k) number K781522. The device is classified under product code LFA. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE VISUAL SPEECH AID?

THE VISUAL SPEECH AID is a medical device that received FDA 510(k) clearance on 1978-11-08. The listed applicant is Exeter Medical Labs, Inc.. The 510(k) number is K781522.

When did THE VISUAL SPEECH AID receive FDA 510(k) clearance?

THE VISUAL SPEECH AID received FDA 510(k) clearance on 1978-11-08, under 510(k) number K781522.

Who is the listed applicant for THE VISUAL SPEECH AID?

The FDA 510(k) record lists Exeter Medical Labs, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE VISUAL SPEECH AID?

The FDA product code for THE VISUAL SPEECH AID is LFA.

Related Clinical Trials

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.

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Other records listing Exeter Medical Labs, 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.

K790554EXETER LIP SEAL

Related Devices (Code: LFA)

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.

K790554EXETER LIP SEALExeter Medical Labs, 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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