The following data is part of a premarket notification filed by Fukuda Denshi Usa, Inc. with the FDA for Arrhythmia System Ac-11.
| Device ID | K841084 |
| 510k Number | K841084 |
| Device Name: | ARRHYTHMIA SYSTEM AC-11 |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | FUKUDA DENSHI USA, INC. 11232 120TH. AVENUE NE Kirkland , WA 98033 - |
| Contact | Robert Steurer |
| Correspondent | Robert Steurer FUKUDA DENSHI USA, INC. 11232 120TH. AVENUE NE Kirkland , WA 98033 - |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-13 |
| Decision Date | 1985-02-01 |