The following data is part of a premarket notification filed by Maquet Cardiopulmonary Ag with the FDA for Heater-cooler Unit Hcu 40.
| Device ID | K130300 |
| 510k Number | K130300 |
| Device Name: | HEATER-COOLER UNIT HCU 40 |
| Classification | Controller, Temperature, Cardiopulmonary Bypass |
| Applicant | MAQUET CARDIOPULMONARY AG 45 BARBOUR POND DRIVE Wayne, NJ 07470 |
| Contact | Helder A Sousa |
| Correspondent | Helder A Sousa MAQUET CARDIOPULMONARY AG 45 BARBOUR POND DRIVE Wayne, NJ 07470 |
| Product Code | DWC |
| CFR Regulation Number | 870.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-07 |
| Decision Date | 2013-07-01 |
| Summary: | summary |