K243437
- 510(k) number
- K243437
- Device name
- mOm Essential Incubator (ME1)
- Applicant
- Mom Incubators Limited GB
- Product code
- FMZ — Incubator, Neonatal
- Decision date
- 2025-08-14
- Date received
- 2024-11-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K243437.pdf
Official FDA record: K243437
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.