The following data is part of a premarket notification filed by Marquette Electronics, Inc. with the FDA for Case 12.
| Device ID | K862316 |
| 510k Number | K862316 |
| Device Name: | CASE 12 |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | MARQUETTE ELECTRONICS, INC. 8200 WEST TOWER AVE. Milwaukee, WI 53223 |
| Contact | Thomas Massopust |
| Correspondent | Thomas Massopust 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 | 1986-06-18 |
| Decision Date | 1986-11-20 |