The following data is part of a premarket notification filed by Aloka Co., Ltd. with the FDA for Aloka Ssd-5500 With Ki And A-sma.
| Device ID | K011457 |
| 510k Number | K011457 |
| Device Name: | ALOKA SSD-5500 WITH KI AND A-SMA |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | ALOKA CO., LTD. 10 FAIRFIELD BLVD. Wallingford, CT 06492 |
| Contact | Kelvin Burroughs |
| Correspondent | Donald J Sherratt INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-05-11 |
| Decision Date | 2001-05-23 |