BCI ADVISOR VITAL SIGNS MONITOR (9200)— 510(k) K010770

Substantially Equivalent

Bci, Inc.

FDA 510(k) clearance K010770 for BCI ADVISOR VITAL SIGNS MONITOR (9200), Substantially Equivalent on 2001-06-12. Applicant: Bci, Inc..

Clearance details

Applicant: Bci, Inc.
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2001-03-14
Decision date: 2001-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, 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.