FDA 510(k)

ADAS 3D

K-Number: K212421 · 2021-09-03

Decision Date2021-09-03

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ADAS 3D is the device name listed in this FDA 510(k) record. The listed applicant is Adas3D Medical S.L.. It received FDA 510(k) clearance on 2021-09-03 under 510(k) number K212421. 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 ADAS 3D?

ADAS 3D is a medical device that received FDA 510(k) clearance on 2021-09-03. The listed applicant is Adas3D Medical S.L.. The 510(k) number is K212421.

When did ADAS 3D receive FDA 510(k) clearance?

ADAS 3D received FDA 510(k) clearance on 2021-09-03, under 510(k) number K212421.

Who is the listed applicant for ADAS 3D?

The FDA 510(k) record lists Adas3D Medical S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADAS 3D?

The FDA product code for ADAS 3D is LLZ.

Other records listing Adas3D Medical S.L. 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.

K253969ADAS 3D K240791ADAS 3D K230803ADAS 3D K210850ADAS 3D

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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.