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FDA 510(k)

3DFIS, MODEL IES-FL-101

K-Number: K013841 · 2002-01-17

Applicant3Dsharp, Inc.
Decision Date2002-01-17
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

3DFIS, MODEL IES-FL-101 is the device name listed in this FDA 510(k) record. The listed applicant is 3Dsharp, Inc.. It received FDA 510(k) clearance on 2002-01-17 under 510(k) number K013841. 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 3DFIS, MODEL IES-FL-101?

3DFIS, MODEL IES-FL-101 is a medical device that received FDA 510(k) clearance on 2002-01-17. The listed applicant is 3Dsharp, Inc.. The 510(k) number is K013841.

When did 3DFIS, MODEL IES-FL-101 receive FDA 510(k) clearance?

3DFIS, MODEL IES-FL-101 received FDA 510(k) clearance on 2002-01-17, under 510(k) number K013841.

Who is the listed applicant for 3DFIS, MODEL IES-FL-101?

The FDA 510(k) record lists 3Dsharp, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3DFIS, MODEL IES-FL-101?

The FDA product code for 3DFIS, MODEL IES-FL-101 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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