G.E. MONITROL 90 AND G.E. MONITROL 15

Table, Radiographic, Tilting

ELECTROMEK DIAGNOSTIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Electromek Diagnostic Systems, Inc. with the FDA for G.e. Monitrol 90 And G.e. Monitrol 15.

Pre-market Notification Details

Device IDK902989
510k NumberK902989
Device Name:G.E. MONITROL 90 AND G.E. MONITROL 15
ClassificationTable, Radiographic, Tilting
Applicant ELECTROMEK DIAGNOSTIC SYSTEMS, INC. 412 ROUTE 40 WEST Troy,  IL  62294
ContactJames Henrichs
CorrespondentJames Henrichs
ELECTROMEK DIAGNOSTIC SYSTEMS, INC. 412 ROUTE 40 WEST Troy,  IL  62294
Product CodeIXR  
CFR Regulation Number892.1980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-06-26
Decision Date1990-10-29

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