510(k) K223127
K223127 is an FDA 510(k) premarket notification submitted by Edwards Lifeciences, LLC for the device "HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable". The FDA issued a decision of Substantially Equivalent on November 7, 2022. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Edwards Lifeciences, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 7, 2022
- Date Received
- October 3, 2022
- Clearance Type
- Special
- 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