The following data is part of a premarket notification filed by Aloka Co., Ltd. with the FDA for Aloka Ust-5280-5.
| Device ID | K002784 |
| 510k Number | K002784 |
| Device Name: | ALOKA UST-5280-5 |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | ALOKA CO., LTD. 10 FAIRFIELD BLVD. Wallingford, CT 06492 |
| Contact | Chris Bohl |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2000-09-06 |
| Decision Date | 2000-09-20 |