The following data is part of a premarket notification filed by Aloka Co., Ltd. with the FDA for Aloka Ssd-1000 Diagnostic Ultrasound System, Models Asu-1003, Ust-9121, Ust-9124.
| Device ID | K020668 |
| 510k Number | K020668 |
| Device Name: | ALOKA SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS ASU-1003, UST-9121, UST-9124 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | ALOKA CO., LTD. 10 FAIRFIELD BLVD. Wallingford, CT 06492 |
| Contact | Kelvin Burroughs |
| Correspondent | Kelvin Burroughs ALOKA CO., LTD. 10 FAIRFIELD BLVD. Wallingford, CT 06492 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-01 |
| Decision Date | 2002-07-10 |
| Summary: | summary |