The following data is part of a premarket notification filed by Vickers America Medical Corp. with the FDA for Treonic C30.
| Device ID | K840823 |
| 510k Number | K840823 |
| Device Name: | TREONIC C30 |
| Classification | Controller, Infusion, Intravascular, Electronic |
| Applicant | VICKERS AMERICA MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LDR |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-02-24 |
| Decision Date | 1984-03-23 |