SURESIGNS VSI VITAL SIGNS MONITOR

System, Measurement, Blood-pressure, Non-invasive

PHILIPS MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Suresigns Vsi Vital Signs Monitor.

Pre-market Notification Details

Device IDK110803
510k NumberK110803
Device Name:SURESIGNS VSI VITAL SIGNS MONITOR
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover,  MA  01810 -1099
ContactMary Kruitwagen
CorrespondentMary Kruitwagen
PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover,  MA  01810 -1099
Product CodeDXN  
Subsequent Product CodeDQA
Subsequent Product CodeFLL
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-03-23
Decision Date2011-05-20
Summary:summary

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