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FDA 510(k)

RAPIDIA

K-Number: K012290 · 2001-09-28

Applicant3D Med Co., Ltd.
Decision Date2001-09-28
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RAPIDIA is the device name listed in this FDA 510(k) record. The listed applicant is 3D Med Co., Ltd.. It received FDA 510(k) clearance on 2001-09-28 under 510(k) number K012290. 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 RAPIDIA?

RAPIDIA is a medical device that received FDA 510(k) clearance on 2001-09-28. The listed applicant is 3D Med Co., Ltd.. The 510(k) number is K012290.

When did RAPIDIA receive FDA 510(k) clearance?

RAPIDIA received FDA 510(k) clearance on 2001-09-28, under 510(k) number K012290.

Who is the listed applicant for RAPIDIA?

The FDA 510(k) record lists 3D Med Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RAPIDIA?

The FDA product code for RAPIDIA is LLZ.

Related Clinical Trials

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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Other records listing 3D Med Co., 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.

K021913CALSCOR SOFTWARE

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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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