The following data is part of a premarket notification filed by Fukuda Denshi Co., Ltd. with the FDA for Uf-760ag.
| Device ID | K110920 |
| 510k Number | K110920 |
| Device Name: | UF-760AG |
| 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 | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | ITX |
| Subsequent Product Code | IYN |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-04-01 |
| Decision Date | 2011-04-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04538612910623 | K110920 | 000 |
| 04538612910289 | K110920 | 000 |
| 04538612908057 | K110920 | 000 |