LIFENET EXCHANGE SYSTEM— 510(k) K052854

Substantially Equivalent

Medtronic Emergency Response Systems, Inc.

FDA 510(k) clearance K052854 for LIFENET EXCHANGE SYSTEM, Substantially Equivalent on 2006-01-20. Applicant: Medtronic Emergency Response Systems, Inc..

Clearance details

Applicant: Medtronic Emergency Response Systems, Inc.
Product code: Code MSX
Advisory panel: Cardiovascular
Date received: 2005-10-11
Decision date: 2006-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, 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.