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 |