The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Max-1 (exercise Electrocardiograph).
| Device ID | K890323 |
| 510k Number | K890323 |
| Device Name: | MAX-1 (EXERCISE ELECTROCARDIOGRAPH) |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | Sandra L Schick |
| Correspondent | Sandra L Schick MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-23 |
| Decision Date | 1989-06-16 |