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FDA 510(k)

BiomarC Fiducial Marker

K-Number: K191797 · 2019-07-29

ApplicantCarbon Medical Technologies
Decision Date2019-07-29
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BiomarC Fiducial Marker is a medical device manufactured by Carbon Medical Technologies. It received FDA 510(k) clearance on 2019-07-29 under approval number K191797. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BiomarC Fiducial Marker?

BiomarC Fiducial Marker is a medical device that received FDA 510(k) clearance on 2019-07-29. It is manufactured by Carbon Medical Technologies. The 510(k) number is K191797.

When was BiomarC Fiducial Marker approved by the FDA?

BiomarC Fiducial Marker received FDA 510(k) clearance on 2019-07-29, under approval number K191797.

What company makes BiomarC Fiducial Marker?

BiomarC Fiducial Marker is manufactured by Carbon Medical Technologies.

What is the FDA product code for BiomarC Fiducial Marker?

The FDA product code for BiomarC Fiducial Marker is IYE.

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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.

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