The following data is part of a premarket notification filed by Vickers America Medical Corp. with the FDA for Model 114 Treonic H150 Haemoheater.
| Device ID | K790936 |
| 510k Number | K790936 |
| Device Name: | MODEL 114 TREONIC H150 HAEMOHEATER |
| Classification | Device, Warming. Blood And Plasma |
| Applicant | VICKERS AMERICA MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KZL |
| CFR Regulation Number | 864.9205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-05-18 |
| Decision Date | 1979-09-04 |