The following data is part of a premarket notification filed by Fukuda Denshi Usa, Inc. with the FDA for Dynascope Monitor Ds-800.
| Device ID | K844348 |
| 510k Number | K844348 |
| Device Name: | DYNASCOPE MONITOR DS-800 |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | FUKUDA DENSHI USA, INC. 12539 130TH LN. NE Kirkland , WA 98034 - |
| Contact | Robert J Steurer |
| Correspondent | Robert J Steurer FUKUDA DENSHI USA, INC. 12539 130TH LN. NE Kirkland , WA 98034 - |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-30 |
| Decision Date | 1984-12-04 |