BM3/BM3 PLUS— 510(k) K132033

Substantially Equivalent

Noblitt & Rueland

FDA 510(k) clearance K132033 for BM3/BM3 PLUS, Substantially Equivalent on 2013-12-04. Applicant: Noblitt & Rueland.

Clearance details

Applicant: Noblitt & Rueland
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2013-07-01
Decision date: 2013-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

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.