WRAP System— 510(k) K260050
Substantially EquivalentHuneo, LLC
FDA 510(k) clearance K260050 for WRAP System, Substantially Equivalent on 2026-07-15. Applicant: Huneo, LLC. Device class: 2.
Summary
Huneo's WRAP System is filed under MNR, ventilatory effort recorders. The record doesn't expand "WRAP" or list the system's components.
Class II, 21 CFR 868.2375. The Neurology review panel handled it as a Traditional 510(k), though the record lists Anesthesiology as the classification panel.
Huneo filed from Willoughby Hills, Ohio. The decision came 189 calendar days after FDA received it (January 7 to July 15, 2026).
Clearance details
- Applicant
- Huneo, LLC
- Product code
- Product code MNR
- Device class
- Class 2
- Regulation
- 21 CFR 868.2375
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Willoughby Hills, OH, US
Recent devices under product code MNR
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