The following data is part of a premarket notification filed by Immersivetouch with the FDA for Immersiveview Surgical Plan (ivsp®).
| Device ID | K181813 |
| 510k Number | K181813 |
| Device Name: | ImmersiveView Surgical Plan (IVSP®) |
| Classification | Driver, Wire, And Bone Drill, Manual |
| Applicant | ImmersiveTouch 708 Kristin Court Westmont, IL 60559 |
| Contact | P. Pat Banerjee |
| Correspondent | P. Pat Banerjee ImmersiveTouch 708 Kristin Court Westmont, IL 60559 |
| Product Code | DZJ |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-06 |
| Decision Date | 2020-06-09 |