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FDA 510(k)

KEYNOTE

K-Number: K863995 · 1986-11-13

Decision Date1986-11-13
Product CodeILQ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

KEYNOTE is the device name listed in this FDA 510(k) record. The listed applicant is Sensory Aids Corp.. It received FDA 510(k) clearance on 1986-11-13 under 510(k) number K863995. 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 KEYNOTE?

KEYNOTE is a medical device that received FDA 510(k) clearance on 1986-11-13. The listed applicant is Sensory Aids Corp.. The 510(k) number is K863995.

When did KEYNOTE receive FDA 510(k) clearance?

KEYNOTE received FDA 510(k) clearance on 1986-11-13, under 510(k) number K863995.

Who is the listed applicant for KEYNOTE?

The FDA 510(k) record lists Sensory Aids Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KEYNOTE?

The FDA product code for KEYNOTE 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.

Other records listing Sensory Aids Corp. 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.

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.

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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