MAGNATEK 30

Oximeter

MAGNA ADVANCED TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Magna Advanced Technologies, Inc. with the FDA for Magnatek 30.

Pre-market Notification Details

Device IDK991819
510k NumberK991819
Device Name:MAGNATEK 30
ClassificationOximeter
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 CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-05-27
Decision Date1999-08-19

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