K223127 is an FDA 510(k) clearance for the HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable. This device is classified as a Computer, Diagnostic, Programmable (Class II - Special Controls, product code DQK).
Submitted by Edwards Lifeciences, LLC (Irvine, US). The FDA issued a Cleared decision on November 7, 2022, 35 days after receiving the submission on October 3, 2022.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1425.
| 510(k) Number | K223127 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 2022 |
| Decision Date | November 07, 2022 |
| Days to Decision | 35 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQK - Computer, Diagnostic, Programmable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1425 |