510(k) K090483 ยท DPS Electrocardiograph
SURSIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VM SERIES PATIENT MONITORS
| Applicant | Philips Medical Systems, Andover MA, US |
| Decision | Substantially Equivalent, Mar 20, 2009 |
| Received | Feb 25, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K090483
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 19, 2020 | Philips North America, LLC Philips SureSigns VM1SpO2, C02, Rec, model no. 863266 - Product Usage: The SureSigns VM1 is a patient monitor that measures oxygen saturation (Sp02), respiration and CO2. The user interface is designe Terminated |
DPS | None listed |
| Jul 13, 2018 | Philips Electronics North America Corporation Philips SureSigns VS2 monitor, 863079
863080
863081
863082
863283
863286
The Sure Signs VS2 vital signs monitor is for use by healthcare professionals whenever there is a need for monitoring the phy Open, Classified |
MHX | None listed |
| Jun 17, 2011 | Philips Healthcare Inc. Philips SureSigns VS3 Vital Signs Monitor Models:
VS3 863069, 863070, 453564041251, 453564041261,
VS3 863071, 863072, 863073, 863074, 453564041271, 453564041281, 453564041291, 453564041301
The Sure Terminated |
DPS | None listed |
| Nov 23, 2009 | Philips Healthcare Inc. SureSigns Patient Monitors (VM3, VM4. VM6. VM8):
VM3 3/5 lead ECG/SPo2, Respiration Bedside Patient Monitor with 8.4"display
VM4 3 Lead ECG, NBP, SPo2, optional Predictive Temp Bedsi Terminated |
MHX | None listed |
| Nov 23, 2009 | Philips Healthcare Inc. SureSigns Vital Signs Viewer (VSV):Spot Check Vital Signs Monitor with NBP (options to include Predictive Temperature only; SPo2 only; SPo2 and Recorder only; SPo2 and Predictive Temperature only; or Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.