Decision Date2016-05-24
Product CodeNCX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Hypocore is the device name listed in this FDA 510(k) record. The listed applicant is Novocor Medical Systems, Inc.. It received FDA 510(k) clearance on 2016-05-24 under 510(k) 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. The listed applicant is Novocor Medical Systems, Inc.. The 510(k) number is K153162.
When did Hypocore receive FDA 510(k) clearance?
Hypocore received FDA 510(k) clearance on 2016-05-24, under 510(k) number K153162.
Who is the listed applicant for Hypocore?
The FDA 510(k) record lists Novocor Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Hypocore?
The FDA product code for Hypocore is NCX.
Related Devices (Code: NCX)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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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.