The following data is part of a premarket notification filed by Life-tech, Inc. with the FDA for Ezono 3000.
| Device ID | K120234 |
| 510k Number | K120234 |
| Device Name: | EZONO 3000 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | LIFE-TECH, INC. 13235 N Promenade Blvd Stafford, TX 77477 |
| Contact | Skip Rimer |
| Correspondent | Skip Rimer LIFE-TECH, INC. 13235 N Promenade Blvd Stafford, TX 77477 |
| 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 | No |
| Combination Product | No |
| Date Received | 2012-01-25 |
| Decision Date | 2012-04-19 |