The following data is part of a premarket notification filed by Life-tech, Inc. with the FDA for Vesiscan.
| Device ID | K093485 |
| 510k Number | K093485 |
| Device Name: | VESISCAN |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | LIFE-TECH, INC. 13235 NORTH PROMENADE BLVD. Stafford, TX 77477 |
| Contact | Jeff Kasoff |
| Correspondent | Jeff Kasoff LIFE-TECH, INC. 13235 NORTH PROMENADE BLVD. Stafford, TX 77477 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-09 |
| Decision Date | 2010-03-16 |