The following data is part of a premarket notification filed by Acoustic Medsystems, Inc. with the FDA for Theravision Ultrasound Ablation System And Acoustx Applicators.
| Device ID | K150019 |
| 510k Number | K150019 |
| Device Name: | TheraVision Ultrasound Ablation System And ACOUSTx Applicators |
| Classification | System, Ablation, Ultrasound And Accessories |
| Applicant | ACOUSTIC MEDSYSTEMS, INC. 208 BURWASH AVE. Savoy, IL 61874 |
| Contact | Yvonne Schleife |
| Correspondent | Yvonne Schleife ACOUSTIC MEDSYSTEMS, INC. 208 BURWASH AVE. Savoy, IL 61874 |
| Product Code | NTB |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-05 |
| Decision Date | 2016-01-13 |
| Summary: | summary |