The following data is part of a premarket notification filed by Aloka Co., Ltd. with the FDA for Aloka Ssd-alpha 10 Ultrasound System.
| Device ID | K043196 |
| 510k Number | K043196 |
| Device Name: | ALOKA SSD-ALPHA 10 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 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 | 2004-11-18 |
| Decision Date | 2004-11-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04562122955553 | K043196 | 000 |
| 04562122954761 | K043196 | 000 |
| 04562122954754 | K043196 | 000 |
| 04562122952095 | K043196 | 000 |
| 04562122952071 | K043196 | 000 |