SATELLITE K+ BLOOD POTASSIUM MONITORING SYSTEM

Electrode, Ion Specific, Potassium

MEDISENSE, INC.

The following data is part of a premarket notification filed by Medisense, Inc. with the FDA for Satellite K+ Blood Potassium Monitoring System.

Pre-market Notification Details

Device IDK897110
510k NumberK897110
Device Name:SATELLITE K+ BLOOD POTASSIUM MONITORING SYSTEM
ClassificationElectrode, Ion Specific, Potassium
Applicant MEDISENSE, INC. 128 SIDNEY ST. Cambridge,  MA  02139
ContactLias, Ph.d.
CorrespondentLias, Ph.d.
MEDISENSE, INC. 128 SIDNEY ST. Cambridge,  MA  02139
Product CodeCEM  
CFR Regulation Number862.1600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-12-26
Decision Date1990-02-27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.