FDA 510(k) K191402, Heater-Cooler System 3T, by Livanova Deutschland, GmbH
FDA 510(k) K191402, Heater-Cooler System 3T, by Livanova Deutschland, GmbH
| 510(k) Number | K191402 |
| Device Classification Name | Controller, Temperature, Cardiopulmonary Bypass |
| Device Name | Heater-Cooler System 3T |
| Applicant | Livanova Deutschland, GmbH Lindberghstrasse 25 Munich, DE 80939 |
| Regulation Number | 870.425 |
| Classification Product Code | DWC |
| Date Received | 05/24/2019 |
| Decision Date | 02/25/2020 |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | Cardiovascular |
| 510k Review Panel | Cardiovascular |
| Type | Traditional |
| Reviewed by Third Party | No |
| Combination Product | No |
| Total Pages | 10390 |
| Redacted Pages | 8311 |
| Unredacted Pages | 2079 |
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