The following data is part of a premarket notification filed by Columbus Instruments Intl. Corp. with the FDA for Cardiomax-ii.
| Device ID | K861543 |
| 510k Number | K861543 |
| Device Name: | CARDIOMAX-II |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | COLUMBUS INSTRUMENTS INTL. CORP. P.O. BOX 44049 Columbus, OH 43204 |
| Contact | Karen Carter |
| Correspondent | Karen Carter COLUMBUS INSTRUMENTS INTL. CORP. P.O. BOX 44049 Columbus, OH 43204 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-24 |
| Decision Date | 1987-03-10 |