The following data is part of a premarket notification filed by Cardiac Pacemakers, Inc. with the FDA for Handheld Pacemaker Programmer & Softwar.
| Device ID | K842364 |
| 510k Number | K842364 |
| Device Name: | HANDHELD PACEMAKER PROGRAMMER & SOFTWAR |
| Classification | Programmer, Pacemaker |
| Applicant | CARDIAC PACEMAKERS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KRG |
| CFR Regulation Number | 870.3700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-18 |
| Decision Date | 1984-09-24 |