FDA 510(k)

AOI UNIVERSAL ULTRASONIC HANDPIECE

K-Number: K950880 · 1995-05-26

Decision Date1995-05-26

Product CodeHQC

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

AOI UNIVERSAL ULTRASONIC HANDPIECE 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 1995-05-26 under 510(k) number K950880. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AOI UNIVERSAL ULTRASONIC HANDPIECE?

AOI UNIVERSAL ULTRASONIC HANDPIECE is a medical device that received FDA 510(k) clearance on 1995-05-26. The listed applicant is American Optical Corp.. The 510(k) number is K950880.

When did AOI UNIVERSAL ULTRASONIC HANDPIECE receive FDA 510(k) clearance?

AOI UNIVERSAL ULTRASONIC HANDPIECE received FDA 510(k) clearance on 1995-05-26, under 510(k) number K950880.

Who is the listed applicant for AOI UNIVERSAL ULTRASONIC HANDPIECE?

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 AOI UNIVERSAL ULTRASONIC HANDPIECE?

The FDA product code for AOI UNIVERSAL ULTRASONIC HANDPIECE is HQC.

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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.