MONACO RTP SYSTEM

System, Planning, Radiation Therapy Treatment

COMPUTERIZED MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Computerized Medical Systems, Inc. with the FDA for Monaco Rtp System.

Pre-market Notification Details

Device IDK071938
510k NumberK071938
Device Name:MONACO RTP SYSTEM
ClassificationSystem, Planning, Radiation Therapy Treatment
Applicant COMPUTERIZED MEDICAL SYSTEMS, INC. 1145 CORPORATE LAKE DR. St. Louis,  MO  63132 -1716
ContactKathryn Stinson
CorrespondentKathryn Stinson
COMPUTERIZED MEDICAL SYSTEMS, INC. 1145 CORPORATE LAKE DR. St. Louis,  MO  63132 -1716
Product CodeMUJ  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-07-13
Decision Date2007-10-01
Summary:summary

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