PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500— 510(k) K113183

Substantially Equivalent

Shanghai 3f Electronics Co, Ltd.

FDA 510(k) clearance K113183 for PMS8210A (IRIS) MULTI-PARAMETER PATIENT MONITOR, MODEL CODE 500, Substantially Equivalent on 2012-02-09. Applicant: Shanghai 3f Electronics Co, Ltd..

Clearance details

Applicant: Shanghai 3f Electronics Co, Ltd.
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2011-10-28
Decision date: 2012-02-09
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Echo, OR, US

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Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.