K211465 is an FDA 510(k) clearance for the HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform. This device is classified as a Computer, Diagnostic, Programmable (Class II - Special Controls, product code DQK).
Submitted by Edwards Lfesciences (Irvine, US). The FDA issued a Cleared decision on July 8, 2021, 58 days after receiving the submission on May 11, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1425.
| 510(k) Number | K211465 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 11, 2021 |
| Decision Date | July 08, 2021 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| 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 |