The following data is part of a premarket notification filed by Aloka Co., Ltd. with the FDA for Aloka Ssd-2000 Diagnostic Ultrasound System Modification.
| Device ID | K941652 |
| 510k Number | K941652 |
| Device Name: | ALOKA SSD-2000 DIAGNOSTIC ULTRASOUND SYSTEM MODIFICATION |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| 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 | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-05 |
| Decision Date | 1994-10-21 |