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FDA 510(k)

3D INVIVO BY CSIST

K-Number: K031567 · 2003-10-02

ApplicantChung-Shan Institute of Science and Technology
Decision Date2003-10-02
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

3D INVIVO BY CSIST is the device name listed in this FDA 510(k) record. The listed applicant is Chung-Shan Institute of Science and Technology. It received FDA 510(k) clearance on 2003-10-02 under 510(k) number K031567. 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 3D INVIVO BY CSIST?

3D INVIVO BY CSIST is a medical device that received FDA 510(k) clearance on 2003-10-02. The listed applicant is Chung-Shan Institute of Science and Technology. The 510(k) number is K031567.

When did 3D INVIVO BY CSIST receive FDA 510(k) clearance?

3D INVIVO BY CSIST received FDA 510(k) clearance on 2003-10-02, under 510(k) number K031567.

Who is the listed applicant for 3D INVIVO BY CSIST?

The FDA 510(k) record lists Chung-Shan Institute of Science and Technology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3D INVIVO BY CSIST?

The FDA product code for 3D INVIVO BY CSIST is LLZ.

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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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