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FDA 510(k)

CARESCAPE Central Station V2

K-Number: K162012 · 2016-09-15

ApplicantGE Healthcare
Decision Date2016-09-15
Product CodeDXJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARESCAPE Central Station V2 is a medical device manufactured by GE Healthcare. It received FDA 510(k) clearance on 2016-09-15 under approval number K162012. The device is classified under product code DXJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARESCAPE Central Station V2?

CARESCAPE Central Station V2 is a medical device that received FDA 510(k) clearance on 2016-09-15. It is manufactured by GE Healthcare. The 510(k) number is K162012.

When was CARESCAPE Central Station V2 approved by the FDA?

CARESCAPE Central Station V2 received FDA 510(k) clearance on 2016-09-15, under approval number K162012.

What company makes CARESCAPE Central Station V2?

CARESCAPE Central Station V2 is manufactured by GE Healthcare.

What is the FDA product code for CARESCAPE Central Station V2?

The FDA product code for CARESCAPE Central Station V2 is DXJ.

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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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