MRI PATIENT MONITORING SYSTEM TESLA M3— 510(k) K142032

Substantially Equivalent

Mipm Mammendorfer Institut Fur Physik Und Medizin

FDA 510(k) clearance K142032 for MRI PATIENT MONITORING SYSTEM TESLA M3, Substantially Equivalent on 2015-05-07. Applicant: Mipm Mammendorfer Institut Fur Physik Und Medizin.

Clearance details

Applicant: Mipm Mammendorfer Institut Fur Physik Und Medizin
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2014-07-25
Decision date: 2015-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: The Hague, NL

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.