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FDA 510(k)

YES-NO VOICE BOX 7011

K-Number: K901029 · 1990-03-13

ApplicantBaylor Biomedical Services
Decision Date1990-03-13
Product CodeILQ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

YES-NO VOICE BOX 7011 is the device name listed in this FDA 510(k) record. The listed applicant is Baylor Biomedical Services. It received FDA 510(k) clearance on 1990-03-13 under 510(k) number K901029. 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 YES-NO VOICE BOX 7011?

YES-NO VOICE BOX 7011 is a medical device that received FDA 510(k) clearance on 1990-03-13. The listed applicant is Baylor Biomedical Services. The 510(k) number is K901029.

When did YES-NO VOICE BOX 7011 receive FDA 510(k) clearance?

YES-NO VOICE BOX 7011 received FDA 510(k) clearance on 1990-03-13, under 510(k) number K901029.

Who is the listed applicant for YES-NO VOICE BOX 7011?

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

What is the FDA product code for YES-NO VOICE BOX 7011?

The FDA product code for YES-NO VOICE BOX 7011 is ILQ.

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 Baylor Biomedical Services 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.

K901030ROTARY COMMUNICATION SCANNER MODEL 7010K901028ENVIRONMENTAL CONTROL UNIT MODEL 7000K900969REMOTE CONTROL SWITCH

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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