CONNEXALL SUITE OF SOFTWARE PRODUCTS— 510(k) K112650

Substantially Equivalent

Connexall USA, Inc.

FDA 510(k) clearance K112650 for CONNEXALL SUITE OF SOFTWARE PRODUCTS, Substantially Equivalent on 2012-02-01. Applicant: Connexall USA, Inc..

Clearance details

Applicant: Connexall USA, Inc.
Product code: Code MSX
Advisory panel: Cardiovascular
Date received: 2011-09-12
Decision date: 2012-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nederland, CO, US

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Adverse events under product code MSX

product code MSX

Death: 59
Total: 59

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.