BRAUN PRECISION SENSOR PRO, MODEL BP 2590— 510(k) K012035

Substantially Equivalent

Braun GmbH

FDA 510(k) clearance K012035 for BRAUN PRECISION SENSOR PRO, MODEL BP 2590, Substantially Equivalent on 2001-07-27. Applicant: Braun GmbH.

Clearance details

Applicant: Braun GmbH
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2001-06-29
Decision date: 2001-07-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Carlsbad, CA, 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.