The following data is part of a premarket notification filed by Alliance Medical, Inc. with the FDA for Echo. Akho.
| Device ID | K951976 |
| 510k Number | K951976 |
| Device Name: | ECHO. AKHO |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | ALLIANCE MEDICAL, INC. 3610 VALIQUETTE ST. St-laurent, Quebec, CA H4s 1x8 |
| Contact | Karim Menassa |
| Correspondent | Karim Menassa ALLIANCE MEDICAL, INC. 3610 VALIQUETTE ST. St-laurent, Quebec, CA H4s 1x8 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-27 |
| Decision Date | 1996-07-26 |