K190205 is an FDA 510(k) clearance for the HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module. This device is classified as a Computer, Diagnostic, Programmable (Class II - Special Controls, product code DQK).
Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on August 29, 2019, 206 days after receiving the submission on February 4, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1425.
| 510(k) Number | K190205 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 2019 |
| Decision Date | August 29, 2019 |
| Days to Decision | 206 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 |