BLOOD MONITORING UNIT, MODEL BMU 40— 510(k) K090147

Substantially Equivalent

Maquet Cardiopulmonary, AG

FDA 510(k) clearance K090147 for BLOOD MONITORING UNIT, MODEL BMU 40, Substantially Equivalent on 2009-04-22. Applicant: Maquet Cardiopulmonary, AG.

Clearance details

Applicant: Maquet Cardiopulmonary, AG
Product code: Code DRY
Advisory panel: Cardiovascular
Date received: 2009-01-21
Decision date: 2009-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hirrlingen, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRY

product code DRY

Death: 5
Total: 5

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.