FDA 510(k)

exoplan 2.3

K-Number: K183458 · 2019-08-06

Decision Date2019-08-06

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

exoplan 2.3 is the device name listed in this FDA 510(k) record. The listed applicant is Exocad GmbH. It received FDA 510(k) clearance on 2019-08-06 under 510(k) number K183458. 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 exoplan 2.3?

exoplan 2.3 is a medical device that received FDA 510(k) clearance on 2019-08-06. The listed applicant is Exocad GmbH. The 510(k) number is K183458.

When did exoplan 2.3 receive FDA 510(k) clearance?

exoplan 2.3 received FDA 510(k) clearance on 2019-08-06, under 510(k) number K183458.

Who is the listed applicant for exoplan 2.3?

The FDA 510(k) record lists Exocad GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for exoplan 2.3?

The FDA product code for exoplan 2.3 is LLZ.

Other records listing Exocad GmbH 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.

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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.