FDA 510(k)

Simplicit90Y

K-Number: K182016 · 2018-12-06

Decision Date2018-12-06

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Simplicit90Y is the device name listed in this FDA 510(k) record. The listed applicant is Mirada Medical, Ltd.. It received FDA 510(k) clearance on 2018-12-06 under 510(k) 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. The listed applicant is Mirada Medical, Ltd.. The 510(k) number is K182016.

When did Simplicit90Y receive FDA 510(k) clearance?

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

Who is the listed applicant for Simplicit90Y?

The FDA 510(k) record lists Mirada Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Simplicit90Y?

The FDA product code for Simplicit90Y is LLZ.

Other records listing Mirada Medical, Ltd. as applicant

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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.