The following data is part of a premarket notification filed by Fukuda Denshi Usa, Inc. with the FDA for Modification To Dynascope Series Monitors.
| Device ID | K863914 |
| 510k Number | K863914 |
| Device Name: | MODIFICATION TO DYNASCOPE SERIES MONITORS |
| Classification | Electrocardiograph |
| Applicant | FUKUDA DENSHI USA, INC. 12539 130TH LN. NE Kirkland , WA 98034 - |
| Contact | Don Andresen |
| Correspondent | Don Andresen FUKUDA DENSHI USA, INC. 12539 130TH LN. NE Kirkland , WA 98034 - |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-08 |
| Decision Date | 1987-01-06 |