DSBClass II

Plethysmograph, Impedance

Cardiovascular · 21 CFR 870.2770

MDR events6All time

Recalls2All time

Registered firms147Currently listed

510(k) clearances114All time

Recent MDR events

6 adverse event reports on file

Event type breakdown

Malfunction6

Most-reported manufacturers

Edwards Lifesciences Irvine3 Edwards Life Sciences1 Edwards Lifesciences Bmeye1 Non Invasive Medical Technologies1

Recalls

2 recall events for this product code

Baxter Healthcare Corporation
Open, ClassifiedSep 26, 2022
Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products); and accessories/spare parts Starling Battery Pack, Product
Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards.
Z-1817-2022 · View FDA record ↗
Partners In Medicine Llc
TerminatedJan 4, 2016
CNSystems TASK FORCE MONITOR 3040i, plethysmograph, impedance. Noninvasively measure and display patient's hemodynamic parameters time synchronized using Imped
Device non-conformity which may lead to an incorrect oscillometric measurement of upper arm blood pressure values in some subjects - mainly in tall and slim persons (overestimation of systolic blood pressure, underestimation of diastolic blood pressure).
Z-0572-2016 · View FDA record ↗

Registered firms

147 firms currently registered for this product code

510(k) clearances

114 clearances for this product code