C-Qual M™ Breastboard; Monarch™ Overhead Arm Positioner

Accelerator, Linear, Medical

MEDTEC, Inc. Dba CIVCO Medical Solutions And CIVCO

The following data is part of a premarket notification filed by Medtec, Inc. Dba Civco Medical Solutions And Civco with the FDA for C-qual M™ Breastboard; Monarch™ Overhead Arm Positioner.

Pre-market Notification Details

Device IDK211001
510k NumberK211001
Device Name:C-Qual M™ Breastboard; Monarch™ Overhead Arm Positioner
ClassificationAccelerator, Linear, Medical
Applicant MEDTEC, Inc. Dba CIVCO Medical Solutions And CIVCO Radiotherapy 1401 8th Street SE Orange City,  IA  51041
ContactAlena Newgren
CorrespondentAlena Newgren
MEDTEC, Inc. Dba CIVCO Medical Solutions And CIVCO 1401 8th Street SE Orange City,  IA  51041
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-02
Decision Date2021-05-20

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