The following data is part of a premarket notification filed by Fukuda Denshi Usa, Inc. with the FDA for Model Fb-20 Non-invasive Blood Pressure Monitor.
| Device ID | K861504 |
| 510k Number | K861504 |
| Device Name: | MODEL FB-20 NON-INVASIVE BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| 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 | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-23 |
| Decision Date | 1986-08-25 |