The following data is part of a premarket notification filed by Fukuda Denshi Usa, Inc. with the FDA for Fukuda Denshi Ff Sonic Uf-5800 General Purpose Ultrasound Scanning System With Doppler.
| Device ID | K990401 |
| 510k Number | K990401 |
| Device Name: | FUKUDA DENSHI FF SONIC UF-5800 GENERAL PURPOSE ULTRASOUND SCANNING SYSTEM WITH DOPPLER |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| 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 | IYO |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYN |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-09 |
| Decision Date | 1999-10-15 |
| Summary: | summary |