SureSigns VS3, SureSigns VS4

Alarm, Blood-pressure

PHILLIPS MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Phillips Medical Systems with the FDA for Suresigns Vs3, Suresigns Vs4.

Pre-market Notification Details

Device IDK151761
510k NumberK151761
Device Name:SureSigns VS3, SureSigns VS4
ClassificationAlarm, Blood-pressure
Applicant PHILLIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover,  MA  01810
ContactGreg Li
CorrespondentGreg Li
PHILLIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. Andover,  MA  01810
Product CodeDSJ  
Subsequent Product CodeCCK
Subsequent Product CodeDSK
Subsequent Product CodeFLL
CFR Regulation Number870.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-06-29
Decision Date2015-09-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838028890 K151761 000

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