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FDA 510(k)

MIRADA RTX

K-Number: K130393 · 2013-03-20

ApplicantMirada Medical, Ltd.
Decision Date2013-03-20
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MIRADA RTX 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 2013-03-20 under 510(k) number K130393. 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 MIRADA RTX?

MIRADA RTX is a medical device that received FDA 510(k) clearance on 2013-03-20. The listed applicant is Mirada Medical, Ltd.. The 510(k) number is K130393.

When did MIRADA RTX receive FDA 510(k) clearance?

MIRADA RTX received FDA 510(k) clearance on 2013-03-20, under 510(k) number K130393.

Who is the listed applicant for MIRADA RTX?

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 MIRADA RTX?

The FDA product code for MIRADA RTX is LLZ.

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Other records listing Mirada Medical, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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