The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Hyper-hypothermia Unit Hypo 10-200.
| Device ID | K831677 |
| 510k Number | K831677 |
| Device Name: | HYPER-HYPOTHERMIA UNIT HYPO 10-200 |
| Classification | Controller, Temperature, Cardiopulmonary Bypass |
| Applicant | GAMBRO, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DWC |
| CFR Regulation Number | 870.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-23 |
| Decision Date | 1983-07-18 |