CLINICAL ALERT NOTIFICATION— 510(k) K130339

Substantially Equivalent

Extension , Inc.

FDA 510(k) clearance K130339 for CLINICAL ALERT NOTIFICATION, Substantially Equivalent on 2013-07-11. Applicant: Extension , Inc..

Clearance details

Applicant: Extension , Inc.
Product code: Code MSX
Advisory panel: Cardiovascular
Date received: 2013-02-11
Decision date: 2013-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaverton, OR, 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.