The following data is part of a premarket notification filed by Aloka Co., Ltd. with the FDA for Ssd-2000 Diag. Ultrasound Sys.&ust-979-3.5 Trans..
| Device ID | K925646 |
| 510k Number | K925646 |
| Device Name: | SSD-2000 DIAG. ULTRASOUND SYS.&UST-979-3.5 TRANS. |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| 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 | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-09 |
| Decision Date | 1993-02-12 |