The following data is part of a premarket notification filed by Livanova Deutschland Gmbh with the FDA for Heater-cooler System 3t.
| Device ID | K191402 |
| 510k Number | K191402 |
| Device Name: | Heater-Cooler System 3T |
| Classification | Controller, Temperature, Cardiopulmonary Bypass |
| Applicant | LivaNova Deutschland GmbH Lindberghstrasse 25 Munich, DE 80939 |
| Contact | Scott Light |
| Product Code | DWC |
| CFR Regulation Number | 870.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-24 |
| Decision Date | 2020-02-25 |
| Summary: | summary |