The following data is part of a premarket notification filed by Fukuda Denshi Usa, Inc. with the FDA for Model U-1000 Ultrasonic Scanner.
| Device ID | K851902 |
| 510k Number | K851902 |
| Device Name: | MODEL U-1000 ULTRASONIC SCANNER |
| Classification | Imager, Ultrasonic Obstetric-gynecologic |
| 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 | HEM |
| CFR Regulation Number | 884.2225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-30 |
| Decision Date | 1985-09-27 |