The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Mx1002 Cable-cal Tm.
| Device ID | K880696 |
| 510k Number | K880696 |
| Device Name: | MX1002 CABLE-CAL TM |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | MEDEX, INC. 3637 LACON RD. Hillard, OH 43026 |
| Contact | Mark T Sondrini |
| Correspondent | Mark T Sondrini MEDEX, INC. 3637 LACON RD. Hillard, OH 43026 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-22 |
| Decision Date | 1988-06-15 |