K230379
- 510(k) number
- K230379
- Device name
- Portable (Ultrasonic) Nebulizer
- Applicant
- Dongguan Simzo Electronic Technology Co., Ltd. CN
- Product code
- CAF — Nebulizer (Direct Patient Interface)
- Decision date
- 2023-11-27
- Date received
- 2023-02-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K230379.pdf
Official FDA record: K230379
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.