The following data is part of a premarket notification filed by Fukuda Denshi Usa, Inc. with the FDA for Fukuda Denshi Ultrasound Scanners Models Uf-3500 And Uf-4500.
| Device ID | K981404 |
| 510k Number | K981404 |
| Device Name: | FUKUDA DENSHI ULTRASOUND SCANNERS MODELS UF-3500 AND UF-4500 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | FUKUDA DENSHI USA, INC. 17725 N.E. 65TH ST., BLDG. C Redmond, WA 98052 -4911 |
| Contact | David J Geraghty |
| Correspondent | David J Geraghty FUKUDA DENSHI USA, INC. 17725 N.E. 65TH ST., BLDG. C Redmond, WA 98052 -4911 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-17 |
| Decision Date | 1998-05-20 |
| Summary: | summary |