K260050
- 510(k) number
- K260050
- Device name
- WRAP System
- Applicant
- Huneo, LLC OH · US
- Product code
- MNR — Ventilatory Effort Recorder
- Decision date
- 2026-07-15
- Date received
- 2026-01-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K260050.pdf
Official FDA record: K260050
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.