Merge Hemo
K-Number: K152864 · 2016-04-07
ApplicantMerge Healthcare Incorporated
Decision Date2016-04-07
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Merge Hemo is a medical device manufactured by Merge Healthcare Incorporated. It received FDA 510(k) clearance on 2016-04-07 under approval number K152864. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Merge Hemo?
Merge Hemo is a medical device that received FDA 510(k) clearance on 2016-04-07. It is manufactured by Merge Healthcare Incorporated. The 510(k) number is K152864.
When was Merge Hemo approved by the FDA?
Merge Hemo received FDA 510(k) clearance on 2016-04-07, under approval number K152864.
What company makes Merge Hemo?
Merge Hemo is manufactured by Merge Healthcare Incorporated.
What is the FDA product code for Merge Hemo?
The FDA product code for Merge Hemo is DQK.
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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.