Hybrid3D
K-Number: K163394 · 2017-05-22
ApplicantHermes Medical Solutions AB
Decision Date2017-05-22
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Hybrid3D is a medical device manufactured by Hermes Medical Solutions AB. It received FDA 510(k) clearance on 2017-05-22 under approval number K163394. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Hybrid3D?
Hybrid3D is a medical device that received FDA 510(k) clearance on 2017-05-22. It is manufactured by Hermes Medical Solutions AB. The 510(k) number is K163394.
When was Hybrid3D approved by the FDA?
Hybrid3D received FDA 510(k) clearance on 2017-05-22, under approval number K163394.
What company makes Hybrid3D?
Hybrid3D is manufactured by Hermes Medical Solutions AB.
What is the FDA product code for Hybrid3D?
The FDA product code for Hybrid3D is KPS.
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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.