The following data is part of a premarket notification filed by Surgical Theater, Inc. with the FDA for Surgical Planner (srp) Brainstorm.
| Device ID | K201465 |
| 510k Number | K201465 |
| Device Name: | SuRgical Planner (SRP) BrainStorm |
| Classification | System, Image Processing, Radiological |
| Applicant | Surgical Theater, Inc. 781 Beta Drive Mayfield Village, OH 44143 |
| Contact | Kevin Murrock |
| Correspondent | Kevin Murrock Surgical Theater, Inc. 781 Beta Drive Mayfield Village, OH 44143 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-02 |
| Decision Date | 2020-07-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860003884119 | K201465 | 000 |