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FDA 510(k)

CALSCOR SOFTWARE

K-Number: K021913 · 2002-09-06

Applicant3D Med Co., Ltd.
Decision Date2002-09-06
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CALSCOR SOFTWARE 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 2002-09-06 under 510(k) number K021913. 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 CALSCOR SOFTWARE?

CALSCOR SOFTWARE is a medical device that received FDA 510(k) clearance on 2002-09-06. The listed applicant is 3D Med Co., Ltd.. The 510(k) number is K021913.

When did CALSCOR SOFTWARE receive FDA 510(k) clearance?

CALSCOR SOFTWARE received FDA 510(k) clearance on 2002-09-06, under 510(k) number K021913.

Who is the listed applicant for CALSCOR SOFTWARE?

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 CALSCOR SOFTWARE?

The FDA product code for CALSCOR SOFTWARE is LLZ.

Related Clinical Trials

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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.

K012290RAPIDIA

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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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