| CardiMax FCP-8100 | 04538612913488 | Fukuda Denshi Co., Ltd. | Class IIa | |
| CardiMax FX-8100 | 04538612913471 | Fukuda Denshi Co., Ltd. | Class IIa | |
| CardiMax FX-8200 | 04538612913495 | Fukuda Denshi Co., Ltd. | Class IIa | |
| CardiMax FX-8300 | 04538612914287 | Fukuda Denshi Co., Ltd. | Class IIa | |
| CardiMax FX-8400 | 04538612914317 | Fukuda Denshi Co., Ltd. | Class IIa | |
| CardiMax FX-9800 | 04538612916021 | Fukuda Denshi Co., Ltd. | Class IIa | |
| ECG AMP Module | 04538612100970 | Fukuda Denshi Co., Ltd. | Class IIa | |
| ECG AMP Module for LP and 15-lead | 04538612100987 | Fukuda Denshi Co., Ltd. | Class IIa | |
| ECG Interpretation Software | 04538612914324 | Fukuda Denshi Co., Ltd. | Class IIa | |
| ECG Interpretation Software | 04538612916007 | Fukuda Denshi Co., Ltd. | Class IIa | |
| ECG INTERPRETATION SOFTWARE | 04538612913501 | Fukuda Denshi Co., Ltd. | Class IIa | |
| ECG INTERPRETATION SOFTWARE | 04538612914294 | Fukuda Denshi Co., Ltd. | Class IIa | |
| LP Testing Software | 04538612916014 | Fukuda Denshi Co., Ltd. | Class IIa | |
| Stress Test Package | 04538612914331 | Fukuda Denshi Co., Ltd. | Class IIa | |
| Wireless Patient Module | 04538612915987 | Fukuda Denshi Co., Ltd. | Class IIa | |
UDI Compass