MRI PATIENT MONITORING SYSTEM (MODEL 865214)— 510(k) K124061

Substantially Equivalent

Invivo Corporation

FDA 510(k) clearance K124061 for MRI PATIENT MONITORING SYSTEM (MODEL 865214), Substantially Equivalent on 2013-02-22. Applicant: Invivo Corporation.

Clearance details

Applicant: Invivo Corporation
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2012-12-31
Decision date: 2013-02-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Orlando, FL, 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.