Vital Sync Informatics Manager & Virtual Patient Monitoring Platform— 510(k) K160718
Substantially EquivalentCovidien
FDA 510(k) clearance K160718 for Vital Sync Informatics Manager & Virtual Patient Monitoring Platform, Substantially Equivalent on 2016-11-14. Applicant: Covidien. Device class: 2.
Clearance details
- Applicant
- Covidien
- 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
- Boulder, CO, US
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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 →
Recalls naming K160718
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K160718.
Data sourced from openFDA. This site is unofficial and independent of the FDA.