COMBITRANS MONITORING SETS AND ACCESSORIES— 510(k) K102033

Substantially Equivalent

B.Braun Melsungen AG

FDA 510(k) clearance K102033 for COMBITRANS MONITORING SETS AND ACCESSORIES, Substantially Equivalent on 2011-04-07. Applicant: B.Braun Melsungen AG.

Clearance details

Applicant: B.Braun Melsungen AG
Product code: Code DRS
Advisory panel: Cardiovascular
Date received: 2010-07-19
Decision date: 2011-04-07
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Allentown, PA, US

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Adverse events under product code DRS

product code DRS

Death: 8
Malfunction: 776
Total: 784

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.