MTEK-1400

Analyzer, Gas, Carbon-dioxide, Gaseous-phase

MAGNA ADVANCED TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Magna Advanced Technologies, Inc. with the FDA for Mtek-1400.

Pre-market Notification Details

Device IDK982846
510k NumberK982846
Device Name:MTEK-1400
ClassificationAnalyzer, Gas, Carbon-dioxide, Gaseous-phase
Applicant MAGNA ADVANCED TECHNOLOGIES, INC. 7200 N.W. SEVENTH ST. 2ND FLOOR Miami,  FL  33126
ContactAnnie Velez
CorrespondentAnnie Velez
MAGNA ADVANCED TECHNOLOGIES, INC. 7200 N.W. SEVENTH ST. 2ND FLOOR Miami,  FL  33126
Product CodeCCK  
CFR Regulation Number868.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-08-12
Decision Date1998-09-18

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