The following data is part of a premarket notification filed by Fukuda Denshi Usa, Inc. with the FDA for Model Ds-504 Dynascope Patient Monitor.
| Device ID | K893405 |
| 510k Number | K893405 |
| Device Name: | MODEL DS-504 DYNASCOPE PATIENT MONITOR |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | FUKUDA DENSHI USA, INC. 7102-A 180TH AVENUE NORTHEAST Redmond, WA 98052 |
| Contact | Robert Steurer |
| Correspondent | Robert Steurer FUKUDA DENSHI USA, INC. 7102-A 180TH AVENUE NORTHEAST Redmond, WA 98052 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-02 |
| Decision Date | 1989-10-02 |