SureSigns VS3; SureSigns VS4

Alarm, Blood-pressure

Philips Medical Systems

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

Pre-market Notification Details

Device IDK163649
510k NumberK163649
Device Name:SureSigns VS3; SureSigns VS4
ClassificationAlarm, Blood-pressure
Applicant Philips Medical Systems 3000 Minuteman Rd. Andover,  MA  01810
ContactGreg Li
CorrespondentGreg Li
Philips Medical Systems 3000 Minuteman Rd. Andover,  MA  01810
Product CodeDSJ  
Subsequent Product CodeCCK
Subsequent Product CodeDQA
Subsequent Product CodeDSA
Subsequent Product CodeDSK
Subsequent Product CodeDXN
Subsequent Product CodeFLL
CFR Regulation Number870.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-12-23
Decision Date2017-03-31
Summary:summary

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