The following data is part of a premarket notification filed by Fukuda Denshi Usa, Inc. with the FDA for Ultrasound System Model Uf-3500.
| Device ID | K955543 |
| 510k Number | K955543 |
| Device Name: | ULTRASOUND SYSTEM MODEL UF-3500 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | FUKUDA DENSHI USA, INC. 7102 180TH.AVENUE N.E.BLDG.A- STE.101 Redmond, WA 98052 |
| Contact | David J Geraghty |
| Correspondent | David J Geraghty FUKUDA DENSHI USA, INC. 7102 180TH.AVENUE N.E.BLDG.A- STE.101 Redmond, WA 98052 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-05 |
| Decision Date | 1997-02-11 |
| Summary: | summary |