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FDA 510(k)

MIRADA XD

K-Number: K101228 · 2010-06-23

ApplicantMirada Medical, Ltd.
Decision Date2010-06-23
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MIRADA XD 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 2010-06-23 under 510(k) number K101228. 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 XD?

MIRADA XD is a medical device that received FDA 510(k) clearance on 2010-06-23. The listed applicant is Mirada Medical, Ltd.. The 510(k) number is K101228.

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

MIRADA XD received FDA 510(k) clearance on 2010-06-23, under 510(k) number K101228.

Who is the listed applicant for MIRADA XD?

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 XD?

The FDA product code for MIRADA XD 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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Related Devices (Code: 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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