FDA 510(k)

Presero 3D Scanning System

K-Number: K190074 · 2019-02-14

Decision Date2019-02-14

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Presero 3D Scanning System is the device name listed in this FDA 510(k) record. The listed applicant is Certis Health. It received FDA 510(k) clearance on 2019-02-14 under 510(k) number K190074. 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 Presero 3D Scanning System?

Presero 3D Scanning System is a medical device that received FDA 510(k) clearance on 2019-02-14. The listed applicant is Certis Health. The 510(k) number is K190074.

When did Presero 3D Scanning System receive FDA 510(k) clearance?

Presero 3D Scanning System received FDA 510(k) clearance on 2019-02-14, under 510(k) number K190074.

Who is the listed applicant for Presero 3D Scanning System?

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

What is the FDA product code for Presero 3D Scanning System?

The FDA product code for Presero 3D Scanning System is LLZ.

Related Devices (Code: LLZ)

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.