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FDA 510(k)

Hura CTP v1.0

K-Number: K212550 · 2021-11-08

ApplicantHura Imaging, Inc.
Decision Date2021-11-08
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Hura CTP v1.0 is a medical device manufactured by Hura Imaging, Inc.. It received FDA 510(k) clearance on 2021-11-08 under approval number K212550. 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 Hura CTP v1.0?

Hura CTP v1.0 is a medical device that received FDA 510(k) clearance on 2021-11-08. It is manufactured by Hura Imaging, Inc.. The 510(k) number is K212550.

When was Hura CTP v1.0 approved by the FDA?

Hura CTP v1.0 received FDA 510(k) clearance on 2021-11-08, under approval number K212550.

What company makes Hura CTP v1.0?

Hura CTP v1.0 is manufactured by Hura Imaging, Inc..

What is the FDA product code for Hura CTP v1.0?

The FDA product code for Hura CTP v1.0 is LLZ.

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Official Source

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