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FDA 510(k)

DReal

K-Number: K153519 · 2016-03-16

ApplicantCarevature Medical, Ltd.
Decision Date2016-03-16
Product CodeHBE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DReal is a medical device manufactured by Carevature Medical, Ltd.. It received FDA 510(k) clearance on 2016-03-16 under approval number K153519. The device is classified under product code HBE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DReal?

DReal is a medical device that received FDA 510(k) clearance on 2016-03-16. It is manufactured by Carevature Medical, Ltd.. The 510(k) number is K153519.

When was DReal approved by the FDA?

DReal received FDA 510(k) clearance on 2016-03-16, under approval number K153519.

What company makes DReal?

DReal is manufactured by Carevature Medical, Ltd..

What is the FDA product code for DReal?

The FDA product code for DReal is HBE.

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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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