The following data is part of a premarket notification filed by Fukuda Denshi Usa, Inc. with the FDA for Fukada Denshi Dynascope Model Ds-5300 Patient Monitor.
| Device ID | K964187 |
| 510k Number | K964187 |
| Device Name: | FUKADA DENSHI DYNASCOPE MODEL DS-5300 PATIENT MONITOR |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | FUKUDA DENSHI USA, INC. 55 NORTHERN BLVD., SUITE 410 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk FUKUDA DENSHI USA, INC. 55 NORTHERN BLVD., SUITE 410 Great Neck, NY 11021 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-21 |
| Decision Date | 1997-05-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04538612909924 | K964187 | 000 |
| 04538612039669 | K964187 | 000 |
| 04538612039645 | K964187 | 000 |
| 04538612039638 | K964187 | 000 |
| 04538612039621 | K964187 | 000 |
| 04538612039614 | K964187 | 000 |