FDA 510(k)

AOD4000 DISPOSABLE PAK

K-Number: K931357 · 1994-01-25

Decision Date1994-01-25

Product CodeHQC

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

AOD4000 DISPOSABLE PAK 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 1994-01-25 under 510(k) number K931357. 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 AOD4000 DISPOSABLE PAK?

AOD4000 DISPOSABLE PAK is a medical device that received FDA 510(k) clearance on 1994-01-25. The listed applicant is American Optical Corp.. The 510(k) number is K931357.

When did AOD4000 DISPOSABLE PAK receive FDA 510(k) clearance?

AOD4000 DISPOSABLE PAK received FDA 510(k) clearance on 1994-01-25, under 510(k) number K931357.

Who is the listed applicant for AOD4000 DISPOSABLE PAK?

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 AOD4000 DISPOSABLE PAK?

The FDA product code for AOD4000 DISPOSABLE PAK is HQC.

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Other records listing American Optical Corp. as applicant

K950881PHACO TIP K950880AOI UNIVERSAL ULTRASONIC HANDPIECE K931354P4000 PHACOEMULSIFIER K931358AORP4000 REUSABLE PAK K820790FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3 K813430TISSUE PROCESSING CASSETTES & ACCESS

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Related Devices (Code: 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.