MRI Patient Monitor TeslaDUO— 510(k) K153739
Substantially EquivalentMipm Mammendorfer Institut Fur Physik Und Medizin
FDA 510(k) clearance K153739 for MRI Patient Monitor TeslaDUO, Substantially Equivalent on 2016-06-28. 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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mammendorf, DE
Adverse events under product code MWI
product code MWI- Death
- 16
- Malfunction
- 963
- Total
- 979
Source: openFDA MAUDE database, through . 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.