BCM 400CP— 510(k) K946378

Substantially Equivalent

B C Medical , Ltd.

FDA 510(k) clearance K946378 for BCM 400CP, Substantially Equivalent on 1995-05-04. Applicant: B C Medical , Ltd..

Clearance details

Applicant: B C Medical , Ltd.
Product code: Code IZI
Advisory panel: Radiology
Date received: 1994-12-23
Decision date: 1995-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: J3y 7p9, CA

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Adverse events under product code IZI

product code IZI

Death: 9
Malfunction: 5,312
Total: 5,321

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.