K242438
- 510(k) number
- K242438
- Device name
- Clearo
- Applicant
- Breas Medical AB SE
- Product code
- NHJ — Device, Positive Pressure Breathing, Intermittent
- Decision date
- 2025-05-16
- Date received
- 2024-08-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K242438.pdf
Official FDA record: K242438
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.