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 IDK133961
510k NumberK133961
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 CodeDQA
Subsequent Product CodeDSA
Subsequent Product CodeDSK
Subsequent Product CodeDXN
Subsequent Product CodeFLL
CFR Regulation Number870.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-12-24
Decision Date2014-06-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838054127 K133961 000

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