510(k) K233326
K233326 is an FDA 510(k) premarket notification submitted by Merge Healthcare Incorporated for the device "Merge Hemo, Model RCSV2". The FDA issued a decision of Substantially Equivalent on June 21, 2024. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Merge Healthcare Incorporated has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 21, 2024
- Date Received
- September 29, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer, Diagnostic, Programmable
- Device Class
- Class II
- Regulation Number
- 870.1425
- Review Panel
- CV
- Submission Type