MINIMON 7137B PATIENT MONITOR

Oximeter

KONTRON INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Kontron Instruments, Inc. with the FDA for Minimon 7137b Patient Monitor.

Pre-market Notification Details

Device IDK895425
510k NumberK895425
Device Name:MINIMON 7137B PATIENT MONITOR
ClassificationOximeter
Applicant KONTRON INSTRUMENTS, INC. 9 PLYMOUTH ST. Everett,  MA  02149
ContactDavid Cromwick
CorrespondentDavid Cromwick
KONTRON INSTRUMENTS, INC. 9 PLYMOUTH ST. Everett,  MA  02149
Product CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-09-07
Decision Date1989-09-26

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