The following data is part of a premarket notification filed by Fukuda Denshi Usa, Inc. with the FDA for Fukuda Denshi Model Ds-3300 Etr.
| Device ID | K897063 |
| 510k Number | K897063 |
| Device Name: | FUKUDA DENSHI MODEL DS-3300 ETR |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | FUKUDA DENSHI USA, INC. 7102-A 180TH AVENUE NORTHEAST Redmond, WA 98052 |
| Contact | Robert J Steurer |
| Correspondent | Robert J Steurer FUKUDA DENSHI USA, INC. 7102-A 180TH AVENUE NORTHEAST Redmond, WA 98052 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-20 |
| Decision Date | 1990-02-01 |