The following data is part of a premarket notification filed by Columbus Instruments Intl. Corp. with the FDA for Cardiotherm-500x.
| Device ID | K771718 |
| 510k Number | K771718 |
| Device Name: | CARDIOTHERM-500X |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | COLUMBUS INSTRUMENTS INTL. CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-09-12 |
| Decision Date | 1977-09-28 |