The following data is part of a premarket notification filed by Fukuda Denshi Usa, Inc. with the FDA for Fukuda Denshi Dynascope Model Ds-5700.
| Device ID | K020084 |
| 510k Number | K020084 |
| Device Name: | FUKUDA DENSHI DYNASCOPE MODEL DS-5700 |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | FUKUDA DENSHI USA, INC. 17725 N.E. 65TH ST., BLDG. C Redmond, WA 98052 -4911 |
| Contact | Larry D Walker |
| Correspondent | Larry D Walker 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 | 2002-01-10 |
| Decision Date | 2002-02-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04538612912061 | K020084 | 000 |
| 04538612911217 | K020084 | 000 |
| 04538612909337 | K020084 | 000 |
| 04538612909221 | K020084 | 000 |
| 04538612209925 | K020084 | 000 |
| 04538612054877 | K020084 | 000 |
| 04538612043307 | K020084 | 000 |
| 04538612043291 | K020084 | 000 |
| 04538612043284 | K020084 | 000 |
| 04538612911224 | K020084 | 000 |
| 04538612911231 | K020084 | 000 |
| 04538612908248 | K020084 | 000 |
| 04538612901041 | K020084 | 000 |
| 04947507000163 | K020084 | 000 |
| 04947507000200 | K020084 | 000 |
| 04947507000194 | K020084 | 000 |
| 04947507000095 | K020084 | 000 |
| 04947507000040 | K020084 | 000 |
| 04538612914379 | K020084 | 000 |
| 04538612043277 | K020084 | 000 |