510(k) K232048
K232048 is an FDA 510(k) premarket notification submitted by Icu Medical for the device "Cogent Hemodynamic Monitoring System; Cogent HMS". The FDA issued a decision of Substantially Equivalent on December 20, 2023. The device falls under product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function), a Class II device regulated under 21 CFR 870.1435. Icu Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 2023
- Date Received
- July 10, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer, Diagnostic, Pre-Programmed, Single-Function
- Device Class
- Class II
- Regulation Number
- 870.1435
- Review Panel
- CV
- Submission Type