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FDA 510(k)

Carescape One

K-Number: K190008 · 2019-12-20

ApplicantGE Healthcare
Decision Date2019-12-20
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Carescape One is a medical device manufactured by GE Healthcare. It received FDA 510(k) clearance on 2019-12-20 under approval number K190008. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Carescape One?

Carescape One is a medical device that received FDA 510(k) clearance on 2019-12-20. It is manufactured by GE Healthcare. The 510(k) number is K190008.

When was Carescape One approved by the FDA?

Carescape One received FDA 510(k) clearance on 2019-12-20, under approval number K190008.

What company makes Carescape One?

Carescape One is manufactured by GE Healthcare.

What is the FDA product code for Carescape One?

The FDA product code for Carescape One is MHX.

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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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