The following data is part of a premarket notification filed by Aloka Co., Ltd. with the FDA for Ust-665p-5, Ust-664-5/7.5, Asu-35wl-10, Scu-35.
| Device ID | K922549 |
| 510k Number | K922549 |
| Device Name: | UST-665P-5, UST-664-5/7.5, ASU-35WL-10, SCU-35 |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | ALOKA CO., LTD. 10 FAIRFIELD BLVD. Wallingford, CT 06492 |
| Contact | Carol C Bennett |
| Correspondent | Carol C 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 | 1992-06-01 |
| Decision Date | 1992-09-21 |