ChartCheck

Accelerator, Linear, Medical

Radformation, Inc.

The following data is part of a premarket notification filed by Radformation, Inc. with the FDA for Chartcheck.

Pre-market Notification Details

Device IDK201119
510k NumberK201119
Device Name:ChartCheck
ClassificationAccelerator, Linear, Medical
Applicant Radformation, Inc. 335 Madison Avenue 16th Floor New York,  NY  10017
ContactKurt Sysock
CorrespondentKurt Sysock
Radformation, Inc. 335 Madison Avenue 16th Floor New York,  NY  10017
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-27
Decision Date2020-06-26

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