MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System— 510(k) K160064
Substantially EquivalentInfobionic, Inc.
FDA 510(k) clearance K160064 for MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System, Substantially Equivalent on 2016-03-11. Applicant: Infobionic, Inc.. Device class: 2.
Clearance details
- Applicant
- Infobionic, Inc.
- Product code
- Code QYX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Lowell, MA, US
Recent devices under product code QYX
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view allAdverse events under product code QYX
product code QYX- Death
- 13
- Malfunction
- 526
- Total
- 539
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.