EarlyVue VS30

Alarm, Blood-pressure

Philips Medizin Systeme Boeblingen GmbH

The following data is part of a premarket notification filed by Philips Medizin Systeme Boeblingen Gmbh with the FDA for Earlyvue Vs30.

Pre-market Notification Details

Device IDK190624
510k NumberK190624
Device Name:EarlyVue VS30
ClassificationAlarm, Blood-pressure
Applicant Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard Strasse 2 Boeblingen,  DE 71034
ContactGreg Li
CorrespondentGreg Li
Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard Strasse 2 Boeblingen,  DE 71034
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-11
Decision Date2019-10-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838091412 K190624 000

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