KONTRON PULSE OXIMETER 7840

Oximeter

KONTRON INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Kontron Instruments, Inc. with the FDA for Kontron Pulse Oximeter 7840.

Pre-market Notification Details

Device IDK890299
510k NumberK890299
Device Name:KONTRON PULSE OXIMETER 7840
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 Received1989-01-19
Decision Date1989-03-02

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.