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FDA 510(k)

MISTAR, MODEL V3.2

K-Number: K043350 · 2004-12-15

ApplicantApollo Medical Imaging Technology Pty. , Ltd.
Decision Date2004-12-15
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MISTAR, MODEL V3.2 is the device name listed in this FDA 510(k) record. The listed applicant is Apollo Medical Imaging Technology Pty. , Ltd.. It received FDA 510(k) clearance on 2004-12-15 under 510(k) number K043350. 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 MISTAR, MODEL V3.2?

MISTAR, MODEL V3.2 is a medical device that received FDA 510(k) clearance on 2004-12-15. The listed applicant is Apollo Medical Imaging Technology Pty. , Ltd.. The 510(k) number is K043350.

When did MISTAR, MODEL V3.2 receive FDA 510(k) clearance?

MISTAR, MODEL V3.2 received FDA 510(k) clearance on 2004-12-15, under 510(k) number K043350.

Who is the listed applicant for MISTAR, MODEL V3.2?

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

What is the FDA product code for MISTAR, MODEL V3.2?

The FDA product code for MISTAR, MODEL V3.2 is LLZ.

Related Clinical Trials

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Other records listing Apollo Medical Imaging Technology Pty. , 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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