NuBorne Infant Warmer— 510(k) K173516
Substantially EquivalentInternational Biomedical
FDA 510(k) clearance K173516 for NuBorne Infant Warmer, Substantially Equivalent on 2018-08-17. Applicant: International Biomedical.
Clearance details
- Applicant
- International Biomedical
- Product code
- Code FMT
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Austin, TX, US
Adverse events under product code FMT
product code FMT- Death
- 4
- Malfunction
- 3,074
- Total
- 3,078
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.