The following data is part of a premarket notification filed by Fukuda Denshi Usa, Inc. with the FDA for Fukuda Denshi Ds-1020a & Ds-1040a Dynascopy Series.
| Device ID | K850897 |
| 510k Number | K850897 |
| Device Name: | FUKUDA DENSHI DS-1020A & DS-1040A DYNASCOPY SERIES |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | FUKUDA DENSHI USA, INC. 12539 130TH LN. NE Kirkland , WA 98034 - |
| Contact | Don Andresen |
| Correspondent | Don Andresen FUKUDA DENSHI USA, INC. 12539 130TH LN. NE Kirkland , WA 98034 - |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-04 |
| Decision Date | 1985-04-10 |