The following data is part of a premarket notification filed by Aloka Co., Ltd. with the FDA for Ust-5522-7.5 & Ust-5522l-7.5 Intraoperative Trans..
| Device ID | K925486 |
| 510k Number | K925486 |
| Device Name: | UST-5522-7.5 & UST-5522L-7.5 INTRAOPERATIVE TRANS. |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | ALOKA CO., LTD. 10 FAIRFIELD BLVD. Wallingford, CT 06492 |
| Contact | Carol Bennett |
| Correspondent | Carol Bennett ALOKA CO., LTD. 10 FAIRFIELD BLVD. Wallingford, CT 06492 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-30 |
| Decision Date | 1993-02-12 |