The following data is part of a premarket notification filed by Aloka Co., Ltd. with the FDA for Ssd-2000 Diagnostic Ultrasound System.
| Device ID | K943637 |
| 510k Number | K943637 |
| Device Name: | SSD-2000 DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | ALOKA CO., LTD. 10 FAIRFIELD BLVD. Wallingford, CT 06492 |
| Contact | Paul D Smolenski |
| Correspondent | Paul D Smolenski 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 | 1994-07-27 |
| Decision Date | 1994-12-29 |