The following data is part of a premarket notification filed by Aloka Co., Ltd. with the FDA for Aloka Sd-3500 Ultrasound System.
| Device ID | K060059 |
| 510k Number | K060059 |
| Device Name: | ALOKA SD-3500 ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | ALOKA CO., LTD. 10 FAIRFIELD BLVD. Wallingford, CT 06492 -7502 |
| Contact | Richard J Cehovsky |
| Correspondent | Daniel E Lehtonen INTERTEK TESTING SERVICES 70 CODMAN HILL RD. Boxborough, MA 01719 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-01-09 |
| Decision Date | 2006-01-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04562122957533 | K060059 | 000 |
| 04562122957526 | K060059 | 000 |
| 04562122957045 | K060059 | 000 |
| 04562122957038 | K060059 | 000 |
| 04562122955591 | K060059 | 000 |
| 04562122955539 | K060059 | 000 |
| 04562122955324 | K060059 | 000 |
| 04562122951692 | K060059 | 000 |
| 04562122951685 | K060059 | 000 |