MICROVIT MT-100

Recorder, Magnetic Tape, Medical

SCHILLER AMERICA, INC.

The following data is part of a premarket notification filed by Schiller America, Inc. with the FDA for Microvit Mt-100.

Pre-market Notification Details

Device IDK973735
510k NumberK973735
Device Name:MICROVIT MT-100
ClassificationRecorder, Magnetic Tape, Medical
Applicant SCHILLER AMERICA, INC. 3002 DOW AVE., #138 Tustin,  CA  92780
ContactMarkus Maritz
CorrespondentMarkus Maritz
SCHILLER AMERICA, INC. 3002 DOW AVE., #138 Tustin,  CA  92780
Product CodeDSH  
CFR Regulation Number870.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-09-30
Decision Date1998-08-25
Summary:summary

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