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FDA 510(k)

GENESYS AND THE ROI

K-Number: K910002 · 1991-07-22

ApplicantThe Complete Systems Corp. Genesys
Decision Date1991-07-22
Product CodeJAI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GENESYS AND THE ROI is the device name listed in this FDA 510(k) record. The listed applicant is The Complete Systems Corp. Genesys. It received FDA 510(k) clearance on 1991-07-22 under 510(k) number K910002. The device is classified under product code JAI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENESYS AND THE ROI?

GENESYS AND THE ROI is a medical device that received FDA 510(k) clearance on 1991-07-22. The listed applicant is The Complete Systems Corp. Genesys. The 510(k) number is K910002.

When did GENESYS AND THE ROI receive FDA 510(k) clearance?

GENESYS AND THE ROI received FDA 510(k) clearance on 1991-07-22, under 510(k) number K910002.

Who is the listed applicant for GENESYS AND THE ROI?

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

What is the FDA product code for GENESYS AND THE ROI?

The FDA product code for GENESYS AND THE ROI is JAI.

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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.

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