SuRgical Planner (SRP) BrainStorm

System, Image Processing, Radiological

Surgical Theater, Inc.

The following data is part of a premarket notification filed by Surgical Theater, Inc. with the FDA for Surgical Planner (srp) Brainstorm.

Pre-market Notification Details

Device IDK201465
510k NumberK201465
Device Name:SuRgical Planner (SRP) BrainStorm
ClassificationSystem, Image Processing, Radiological
Applicant Surgical Theater, Inc. 781 Beta Drive Mayfield Village,  OH  44143
ContactKevin Murrock
CorrespondentKevin Murrock
Surgical Theater, Inc. 781 Beta Drive Mayfield Village,  OH  44143
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-02
Decision Date2020-07-17

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