FDA 510(k)

FUL-VUE

K-Number: K782118 · 1979-01-26

Decision Date1979-01-26

Product CodeHKN

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

FUL-VUE is the device name listed in this FDA 510(k) record. The listed applicant is American Optical Corp.. It received FDA 510(k) clearance on 1979-01-26 under 510(k) number K782118. The device is classified under product code HKN. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUL-VUE?

FUL-VUE is a medical device that received FDA 510(k) clearance on 1979-01-26. The listed applicant is American Optical Corp.. The 510(k) number is K782118.

When did FUL-VUE receive FDA 510(k) clearance?

FUL-VUE received FDA 510(k) clearance on 1979-01-26, under 510(k) number K782118.

Who is the listed applicant for FUL-VUE?

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

What is the FDA product code for FUL-VUE?

The FDA product code for FUL-VUE is HKN.

Other records listing American Optical 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.

K950881PHACO TIP K950880AOI UNIVERSAL ULTRASONIC HANDPIECE K931354P4000 PHACOEMULSIFIER K931358AORP4000 REUSABLE PAK K931357AOD4000 DISPOSABLE PAK K820790FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3

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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.