The following data is part of a premarket notification filed by Aloka Co., Ltd. with the FDA for Ssd-5000 Diagnostic Ultrasound System.
| Device ID | K012080 |
| 510k Number | K012080 |
| Device Name: | SSD-5000 DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, 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 | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-03 |
| Decision Date | 2001-08-29 |
| Summary: | summary |