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FDA 510(k)

Hybrid3D

K-Number: K163394 · 2017-05-22

Decision Date2017-05-22
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Hybrid3D is the device name listed in this FDA 510(k) record. The listed applicant is Hermes Medical Solutions AB. It received FDA 510(k) clearance on 2017-05-22 under 510(k) 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. The listed applicant is Hermes Medical Solutions AB. The 510(k) number is K163394.

When did Hybrid3D receive FDA 510(k) clearance?

Hybrid3D received FDA 510(k) clearance on 2017-05-22, under 510(k) number K163394.

Who is the listed applicant for Hybrid3D?

The FDA 510(k) record lists Hermes Medical Solutions AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hybrid3D?

The FDA product code for Hybrid3D is KPS.

Other records listing Hermes Medical Solutions AB 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.

View all 13 devices →

Related Devices (Code: KPS)

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.

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.