K242290
- 510(k) number
- K242290
- Device name
- DormoTech NLab
- Applicant
- Dormotech Medical, Ltd. IL
- Product code
- MNR — Ventilatory Effort Recorder
- Decision date
- 2025-01-08
- Date received
- 2024-08-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K242290.pdf
Official FDA record: K242290
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.