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FDA 510(k)

COMPANION SPEECH AID, MODEL 432

K-Number: K910796 · 1991-03-07

ApplicantCompanion Products Intl.
Decision Date1991-03-07
Product CodeILQ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

COMPANION SPEECH AID, MODEL 432 is the device name listed in this FDA 510(k) record. The listed applicant is Companion Products Intl.. It received FDA 510(k) clearance on 1991-03-07 under 510(k) number K910796. The device is classified under product code ILQ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPANION SPEECH AID, MODEL 432?

COMPANION SPEECH AID, MODEL 432 is a medical device that received FDA 510(k) clearance on 1991-03-07. The listed applicant is Companion Products Intl.. The 510(k) number is K910796.

When did COMPANION SPEECH AID, MODEL 432 receive FDA 510(k) clearance?

COMPANION SPEECH AID, MODEL 432 received FDA 510(k) clearance on 1991-03-07, under 510(k) number K910796.

Who is the listed applicant for COMPANION SPEECH AID, MODEL 432?

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

What is the FDA product code for COMPANION SPEECH AID, MODEL 432?

The FDA product code for COMPANION SPEECH AID, MODEL 432 is ILQ.

Related Clinical Trials

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Other records listing Companion Products Intl. 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.

K910819COMPANION SPEECH AID, MODEL 160

Related Devices (Code: ILQ)

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.

K162817Noddle(TM)Iowa Adaptive Technologies, Inc. Dba Voxello, Inc.K943035P.A.T. SYSTEMMathews Assoc., Inc.K930044COMFORT KEYBOARD SYSTEMHealth Care Keyboard Co., Inc.K931855LIGHTWRITERZygo Corp.K935244R & D BATTERIES, INC. PART NUMBER 5113R & D Batteries, Inc.K935981MLT-2Med 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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