3880 MRI Patient Monitoring System— 510(k) K182900
Substantially EquivalentIradimed Corporation
FDA 510(k) clearance K182900 for 3880 MRI Patient Monitoring System, Substantially Equivalent on 2018-12-14. Applicant: Iradimed Corporation. Device class: 2.
Clearance details
- Applicant
- Iradimed Corporation
- Product code
- Code MWI
- Device class
- Class 2
- Regulation
- 21 CFR 870.2300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Winter Springs, FL, US
Recent devices under product code MWI
view allMore clearances from Iradimed Corporation
view allAdverse 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.