The following data is part of a premarket notification filed by Jostra Ab with the FDA for Heater Cooler Unit, Model Hcu 30.
| Device ID | K031544 |
| 510k Number | K031544 |
| Device Name: | HEATER COOLER UNIT, MODEL HCU 30 |
| Classification | Controller, Temperature, Cardiopulmonary Bypass |
| Applicant | JOSTRA AB 2828 N. CRESCENT RIDGE DR. The Woodlands, TX 77381 |
| Contact | Le Ann Latham |
| Correspondent | Le Ann Latham JOSTRA AB 2828 N. CRESCENT RIDGE DR. The Woodlands, TX 77381 |
| Product Code | DWC |
| CFR Regulation Number | 870.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-16 |
| Decision Date | 2003-08-07 |
| Summary: | summary |