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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: 863283, SureSigns VS4 Vital Sign Monitor; 863379, SureSigns VS4 U.S. Gov NBP. SPO2
Classification Name: COMPUTER, BLOOD-PRESSURE
Product Code: DSK
Device Class: 2
Regulation Number: 870.1110
Medical Specialty: Cardiovascular
Registered Establishment Name: Philips North America LLC
Registered Establishment Number: 1218950
Premarket Submission Number: K163649
Owner/Operator: Philips Medical Systems International BV
Owner/Operator Number: 1217116
Establishment Operations: Complaint File Establishment
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