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FDA 510(k)

Simplicit90Y

K-Number: K182016 · 2018-12-06

ApplicantMirada Medical, Ltd.
Decision Date2018-12-06
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Simplicit90Y is a medical device manufactured by Mirada Medical, Ltd.. It received FDA 510(k) clearance on 2018-12-06 under approval number K182016. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Simplicit90Y?

Simplicit90Y is a medical device that received FDA 510(k) clearance on 2018-12-06. It is manufactured by Mirada Medical, Ltd.. The 510(k) number is K182016.

When was Simplicit90Y approved by the FDA?

Simplicit90Y received FDA 510(k) clearance on 2018-12-06, under approval number K182016.

What company makes Simplicit90Y?

Simplicit90Y is manufactured by Mirada Medical, Ltd..

What is the FDA product code for Simplicit90Y?

The FDA product code for Simplicit90Y is LLZ.

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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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