The following data is part of a premarket notification filed by Fukuda Denshi Usa, Inc. with the FDA for Fukuda Denshi Dynascope, Model Ds-5800nx.
| Device ID | K000746 |
| 510k Number | K000746 |
| Device Name: | FUKUDA DENSHI DYNASCOPE, MODEL DS-5800NX |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | FUKUDA DENSHI USA, INC. 17725 N.E. 65TH ST., BLDG. C Redmond, WA 98052 -4911 |
| Contact | David J Geraghty |
| Correspondent | David J Geraghty FUKUDA DENSHI USA, INC. 17725 N.E. 65TH ST., BLDG. C Redmond, WA 98052 -4911 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-08 |
| Decision Date | 2000-04-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04538612912047 | K000746 | 000 |
| 04538612908354 | K000746 | 000 |
| 04538612908330 | K000746 | 000 |
| 04538612908316 | K000746 | 000 |
| 04538612908293 | K000746 | 000 |
| 04538612014857 | K000746 | 000 |
| 04538612014840 | K000746 | 000 |
| 04538612014833 | K000746 | 000 |