K243468
- 510(k) number
- K243468
- Device name
- Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)
- Applicant
- Joytech Healthcare Co. , Ltd. CN
- Product code
- CAF — Nebulizer (Direct Patient Interface)
- Decision date
- 2025-07-02
- Date received
- 2024-11-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K243468.pdf
Official FDA record: K243468
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.