FDA 510(k)

A O CUSTOM II CHAIR AND STAND

K-Number: K801638 · 1980-08-13

Decision Date1980-08-13

Product CodeHME

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

A O CUSTOM II CHAIR AND STAND 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 1980-08-13 under 510(k) number K801638. The device is classified under product code HME. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A O CUSTOM II CHAIR AND STAND?

A O CUSTOM II CHAIR AND STAND is a medical device that received FDA 510(k) clearance on 1980-08-13. The listed applicant is American Optical Corp.. The 510(k) number is K801638.

When did A O CUSTOM II CHAIR AND STAND receive FDA 510(k) clearance?

A O CUSTOM II CHAIR AND STAND received FDA 510(k) clearance on 1980-08-13, under 510(k) number K801638.

Who is the listed applicant for A O CUSTOM II CHAIR AND STAND?

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 A O CUSTOM II CHAIR AND STAND?

The FDA product code for A O CUSTOM II CHAIR AND STAND is HME.

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Other records listing American Optical Corp. as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.