Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Merge Healthcare Incorporated. It received FDA 510(k) clearance on 2024-06-21 under 510(k) 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. The listed applicant is Merge Healthcare Incorporated. The 510(k) number is K233326.

When did Merge Hemo, Model RCSV2 receive FDA 510(k) clearance?

Merge Hemo, Model RCSV2 received FDA 510(k) clearance on 2024-06-21, under 510(k) number K233326.

Who is the listed applicant for Merge Hemo, Model RCSV2?

The FDA 510(k) record lists Merge Healthcare Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Merge Hemo, Model RCSV2?

The FDA product code for Merge Hemo, Model RCSV2 is DQK.

Other records listing Merge Healthcare Incorporated as applicant

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.

K250301Merge Universal Viewer (MUV)K203104IBM iConnect AccessK192455Merge PACSK192276Merge CardioK182290IBM iConnect AccessK173475Merge PACS

View all 8 devices →

Related Devices (Code: DQK)

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.

K253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLCK253463ILR ECG Analyzer (IM007)Implicity, Inc.K261119NorthStar Mapping System (MAP01 or MAP01-01)Imricor Medical Systems, Inc.K253088OneStim-DUO Cardiac Stimulator (MP5003-4CO)Micropace Pty, Ltd.

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.

↑