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FDA 510(k)

Hypocore

K-Number: K153162 · 2016-05-24

ApplicantNovocor Medical Systems, Inc.
Decision Date2016-05-24
Product CodeNCX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Hypocore is a medical device manufactured by Novocor Medical Systems, Inc.. It received FDA 510(k) clearance on 2016-05-24 under approval number K153162. The device is classified under product code NCX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hypocore?

Hypocore is a medical device that received FDA 510(k) clearance on 2016-05-24. It is manufactured by Novocor Medical Systems, Inc.. The 510(k) number is K153162.

When was Hypocore approved by the FDA?

Hypocore received FDA 510(k) clearance on 2016-05-24, under approval number K153162.

What company makes Hypocore?

Hypocore is manufactured by Novocor Medical Systems, Inc..

What is the FDA product code for Hypocore?

The FDA product code for Hypocore is NCX.

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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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