The following data is part of a premarket notification filed by Fukuda Denshi Co., Ltd. with the FDA for Uf-870 Ag Diagnostic Ultrasound System.
| Device ID | K081919 |
| 510k Number | K081919 |
| Device Name: | UF-870 AG DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | FUKUDA DENSHI CO., LTD. 17725 N.E. 65TH STREET BLDG C Redmond, WA 98052 -4911 |
| Contact | Loran Van Noy |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | ITX |
| Subsequent Product Code | IYN |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-07-07 |
| Decision Date | 2008-09-09 |
| Summary: | summary |