The following data is part of a premarket notification filed by Cardiac Pacemakers, Inc. with the FDA for Mapping Probe Model #6540.
| Device ID | K802058 |
| 510k Number | K802058 |
| Device Name: | MAPPING PROBE MODEL #6540 |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | CARDIAC PACEMAKERS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-08-25 |
| Decision Date | 1980-11-19 |