BCI MODEL 6004 NIBP MONITOR (6004)— 510(k) K970801

Substantially Equivalent

Bci Intl., Inc.

FDA 510(k) clearance K970801 for BCI MODEL 6004 NIBP MONITOR (6004), Substantially Equivalent on 1997-11-12. Applicant: Bci Intl., Inc..

Clearance details

Applicant: Bci Intl., Inc.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 1997-03-04
Decision date: 1997-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

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Adverse events under product code DXN

product code DXN

Death: 3
Injury: 169
Malfunction: 1,019
Other: 2
Total: 1,193

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.