BIONET BM3PLUS PATIENT MONITOR— 510(k) K082008

Substantially Equivalent

Bionet Co., Ltd.

FDA 510(k) clearance K082008 for BIONET BM3PLUS PATIENT MONITOR, Substantially Equivalent on 2008-12-11. Applicant: Bionet Co., Ltd..

Clearance details

Applicant: Bionet Co., Ltd.
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2008-07-15
Decision date: 2008-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Marino, CA, 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.