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FDA 510(k)

RTIST

K-Number: K033955 · 2004-03-17

ApplicantMirada Solutions , Ltd.
Decision Date2004-03-17
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RTIST is the device name listed in this FDA 510(k) record. The listed applicant is Mirada Solutions , Ltd.. It received FDA 510(k) clearance on 2004-03-17 under 510(k) number K033955. 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 RTIST?

RTIST is a medical device that received FDA 510(k) clearance on 2004-03-17. The listed applicant is Mirada Solutions , Ltd.. The 510(k) number is K033955.

When did RTIST receive FDA 510(k) clearance?

RTIST received FDA 510(k) clearance on 2004-03-17, under 510(k) number K033955.

Who is the listed applicant for RTIST?

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

What is the FDA product code for RTIST?

The FDA product code for RTIST is LLZ.

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Other records listing Mirada Solutions , 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.

K020546FUSION 7D

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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.

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