SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VS4 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 Vs3 Vital Signs Monitor, Suresigns Vs4 Vital Signs Monitor.

Pre-market Notification Details

Device IDK120132
510k NumberK120132
Device Name:SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VS4 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 CodeDSA
Subsequent Product CodeDSF
Subsequent Product CodeDSJ
Subsequent Product CodeDSK
Subsequent Product CodeDXG
Subsequent Product CodeFLL
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-01-17
Decision Date2012-02-14
Summary:summary

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