The following data is part of a premarket notification filed by Fukuda Denshi Usa, Inc. with the FDA for Fukuda Denshi Model Ff Sonic Uf-750xt.
| Device ID | K033209 |
| 510k Number | K033209 |
| Device Name: | FUKUDA DENSHI MODEL FF SONIC UF-750XT |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | FUKUDA DENSHI USA, INC. 17725 N.E. 65TH ST., BLDG. C Redmond, WA 98052 -4911 |
| Contact | Larry D Walker |
| Correspondent | Larry D Walker FUKUDA DENSHI USA, INC. 17725 N.E. 65TH ST., BLDG. C Redmond, WA 98052 -4911 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-03 |
| Decision Date | 2003-10-31 |
| Summary: | summary |