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FDA 510(k)

Ilumien Optis, Optis Integrated, Optis Mobile

K-Number: K183320 · 2019-04-02

ApplicantSt. Jude Medical (Now Abbott Medical)
Decision Date2019-04-02
Product CodeNQQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Ilumien Optis, Optis Integrated, Optis Mobile is a medical device manufactured by St. Jude Medical (Now Abbott Medical). It received FDA 510(k) clearance on 2019-04-02 under approval number K183320. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ilumien Optis, Optis Integrated, Optis Mobile?

Ilumien Optis, Optis Integrated, Optis Mobile is a medical device that received FDA 510(k) clearance on 2019-04-02. It is manufactured by St. Jude Medical (Now Abbott Medical). The 510(k) number is K183320.

When was Ilumien Optis, Optis Integrated, Optis Mobile approved by the FDA?

Ilumien Optis, Optis Integrated, Optis Mobile received FDA 510(k) clearance on 2019-04-02, under approval number K183320.

What company makes Ilumien Optis, Optis Integrated, Optis Mobile?

Ilumien Optis, Optis Integrated, Optis Mobile is manufactured by St. Jude Medical (Now Abbott Medical).

What is the FDA product code for Ilumien Optis, Optis Integrated, Optis Mobile?

The FDA product code for Ilumien Optis, Optis Integrated, Optis Mobile is NQQ.

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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.

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