The following data is part of a premarket notification filed by Livanova Deutschland Gmbh with the FDA for Essenz Patient Monitor.
| Device ID | K212003 |
| 510k Number | K212003 |
| Device Name: | ESSENZ Patient Monitor |
| Classification | Display, Cathode-ray Tube, Medical |
| Applicant | LivaNova Deutschland GmbH Lindberghstr. 25 Munich, DE 80939 |
| Contact | Florian Goetz |
| Correspondent | Florian Goetz LivaNova Deutschland GmbH Lindberghstr. 25 Munich, DE 80939 |
| Product Code | DXJ |
| CFR Regulation Number | 870.2450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-28 |
| Decision Date | 2021-11-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04033817903178 | K212003 | 000 |
| 04033817903161 | K212003 | 000 |