MULTIFUNCTION KEITO K5

System, Measurement, Blood-pressure, Non-invasive

BUMEDCO INTL., INC.

The following data is part of a premarket notification filed by Bumedco Intl., Inc. with the FDA for Multifunction Keito K5.

Pre-market Notification Details

Device IDK984083
510k NumberK984083
Device Name:MULTIFUNCTION KEITO K5
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant BUMEDCO INTL., INC. 725 TIMBER LN. Shoreview,  MN  55126
ContactDarrold Glanville
CorrespondentDarrold Glanville
BUMEDCO INTL., INC. 725 TIMBER LN. Shoreview,  MN  55126
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-11-16
Decision Date2000-01-18
Summary:summary

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