The following data is part of a premarket notification filed by Fukuda Denshi Usa, Inc. with the FDA for Model U-1000 With Gestational Age Calculation.
| Device ID | K871385 |
| 510k Number | K871385 |
| Device Name: | MODEL U-1000 WITH GESTATIONAL AGE CALCULATION |
| Classification | System, Monitoring, Perinatal |
| Applicant | FUKUDA DENSHI USA, INC. 12539 130TH LN. NE Kirkland , WA 98034 - |
| Contact | Donald Andresen |
| Correspondent | Donald Andresen FUKUDA DENSHI USA, INC. 12539 130TH LN. NE Kirkland , WA 98034 - |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-07 |
| Decision Date | 1987-05-26 |