K212003 is an FDA 510(k) clearance for the ESSENZ Patient Monitor. This device is classified as a Display, Cathode-ray Tube, Medical (Class II - Special Controls, product code DXJ).
Submitted by Livanova Deutschland, GmbH (Munich, DE). The FDA issued a Cleared decision on November 10, 2021, 135 days after receiving the submission on June 28, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2450.
| 510(k) Number | K212003 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 28, 2021 |
| Decision Date | November 10, 2021 |
| Days to Decision | 135 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXJ - Display, Cathode-ray Tube, Medical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2450 |