SureSigns VS3; SureSigns VS4— 510(k) K163649

Clearance details

Applicant

Philips Medical Systems

Product code

Code DSJ

Device class

Class 2

Regulation

21 CFR 870.1100

Advisory panel

Cardiovascular

Date received

2016-12-23

Decision date

2017-03-31

Decision

Substantially Equivalent

Clearance type

Special

Location

Andover, MA, US

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• Z-1317-2019 — SureSigns VS3 NBP, Product Number 863069. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).Class II·Ongoing·Philips North America, LLC·20190419
• Z-1318-2019 — SureSigns VS3 NBP Temp, Product Number 863070. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).Class II·Ongoing·Philips North America, LLC·20190419
• Z-1319-2019 — SureSigns VS3 NBP, SpO2, Product Number 863071. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).Class II·Ongoing·Philips North America, LLC·20190419
• Z-1320-2019 — SureSigns VS3 NBP, SpO2, Rec, Product Number 863072. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).Class II·Ongoing·Philips North America, LLC·20190419
• Z-1321-2019 — SureSigns VS3 NBP, SpO2, Temp, Product Number 863073. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).Class II·Ongoing·Philips North America, LLC·20190419
• Z-1322-2019 — SureSigns VS3 NBP, SpO2, Temp, Rec, Product Number 863074. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).Class II·Ongoing·Philips North America, LLC·20190419
• Z-1323-2019 — SureSigns VS4 NBP, SpO2, Product Number 863283. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).Class II·Ongoing·Philips North America, LLC·20190419
• Z-1324-2019 — SureSigns VS4 Government Bundle, Product Number 863286. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).Class II·Ongoing·Philips North America, LLC·20190419
• Z-2893-2018 — Philips SureSigns VS3 Vital Signs Monitor, 863069 863070 863071 863072 863073 863074 The SureSigns VS3 monitor is for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.Class II·Ongoing·Philips Electronics North America Corporation·20180713
• Z-2894-2018 — Philips SureSigns VS4 Vital Signs Monitor, 863283 863286 The SureSigns VS4 vital signs monitor is for use by healthcare professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VS4 monitor is for monitoring, recording, and alarming of multiple physiological parameters in healthcare environments for the patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility.Class II·Ongoing·Philips Electronics North America Corporation·20180713

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K163649.