Presero 3D Scanning System
K-Number: K190074 · 2019-02-14
ApplicantCertis Health
Decision Date2019-02-14
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Presero 3D Scanning System is a medical device manufactured by Certis Health. It received FDA 510(k) clearance on 2019-02-14 under approval 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. It is manufactured by Certis Health. The 510(k) number is K190074.
When was Presero 3D Scanning System approved by the FDA?
Presero 3D Scanning System received FDA 510(k) clearance on 2019-02-14, under approval number K190074.
What company makes Presero 3D Scanning System?
Presero 3D Scanning System is manufactured by Certis Health.
What is the FDA product code for Presero 3D Scanning System?
The FDA product code for Presero 3D Scanning System is LLZ.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.