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510(k) K163649 · DSJ Alarm, Blood-Pressure

SureSigns VS3; SureSigns VS4

Applicant	Philips Medical Systems, Andover MA, US
Decision	Substantially Equivalent, Mar 31, 2017
Received	Dec 23, 2016
Type	Special
FDA record	Open on fda.gov

Recalls that name K163649

Date	Firm and product	Code	Linked 510(k)
Apr 19, 2019	Philips North America, LLC SureSigns VS3 NBP, Product Number 863069. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature). Open, Classified	MHX	None listed
Apr 19, 2019	Philips North America, LLC SureSigns VS3 NBP Temp, Product Number 863070. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature). Open, Classified	MHX	None listed
Apr 19, 2019	Philips North America, LLC SureSigns VS3 NBP, SpO2, Product Number 863071. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature). Open, Classified	MHX	None listed
Apr 19, 2019	Philips North America, LLC SureSigns VS3 NBP, SpO2, Rec, Product Number 863072. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature). Open, Classified	MHX	None listed
Apr 19, 2019	Philips North America, LLC SureSigns VS3 NBP, SpO2, Temp, Product Number 863073. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature). Open, Classified	MHX	None listed
Apr 19, 2019	Philips North America, LLC SureSigns VS3 NBP, SpO2, Temp, Rec, Product Number 863074. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature). Open, Classified	MHX	None listed
Apr 19, 2019	Philips North America, LLC SureSigns VS4 NBP, SpO2, Product Number 863283. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature). Open, Classified	MHX	None listed
Apr 19, 2019	Philips North America, LLC SureSigns VS4 Government Bundle, Product Number 863286. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature). Open, Classified	MHX	None listed
Jul 13, 2018	Philips Electronics North America Corporation 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 Open, Classified	MHX	None listed
Jul 13, 2018	Philips Electronics North America Corporation 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 parame Open, Classified	MHX	None listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.