The following data is part of a premarket notification filed by Heuristic Medical Systems, Inc. with the FDA for Contour Electrode.
| Device ID | K844345 |
| 510k Number | K844345 |
| Device Name: | CONTOUR ELECTRODE |
| Classification | Electrode, Electrocardiograph |
| Applicant | HEURISTIC MEDICAL SYSTEMS, INC. P.O. BOX 578 Herrin, IL 62948 |
| Contact | Keith Ferrari |
| Correspondent | Keith Ferrari HEURISTIC MEDICAL SYSTEMS, INC. P.O. BOX 578 Herrin, IL 62948 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-09 |
| Decision Date | 1985-01-02 |