The following data is part of a premarket notification filed by Aloka Co. Ltd Usa with the FDA for Aloka Ssd-alpha 5 Ultrasound System.
| Device ID | K041916 |
| 510k Number | K041916 |
| Device Name: | ALOKA SSD-ALPHA 5 ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | ALOKA CO. LTD USA 10 FAIRFIELD BLVD. Wallingford, CT 06492 |
| Contact | Richard J Cehovsky |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| 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 | 2004-07-16 |
| Decision Date | 2004-07-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04562122956116 | K041916 | 000 |
| 04562122952064 | K041916 | 000 |
| 04573596212738 | K041916 | 000 |