Merge Hemo, Model RCSV2
K-Number: K233326 · 2024-06-21
ApplicantMerge Healthcare Incorporated
Decision Date2024-06-21
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Merge Hemo, Model RCSV2 is a medical device manufactured by Merge Healthcare Incorporated. It received FDA 510(k) clearance on 2024-06-21 under approval number K233326. 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, Model RCSV2?
Merge Hemo, Model RCSV2 is a medical device that received FDA 510(k) clearance on 2024-06-21. It is manufactured by Merge Healthcare Incorporated. The 510(k) number is K233326.
When was Merge Hemo, Model RCSV2 approved by the FDA?
Merge Hemo, Model RCSV2 received FDA 510(k) clearance on 2024-06-21, under approval number K233326.
What company makes Merge Hemo, Model RCSV2?
Merge Hemo, Model RCSV2 is manufactured by Merge Healthcare Incorporated.
What is the FDA product code for Merge Hemo, Model RCSV2?
The FDA product code for Merge Hemo, Model RCSV2 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.