Clearance Summary
WALLABY 4 received FDA 510(k) clearance under submission number K070180, sponsored by Respironics Inc., Sleep & Home Respiratory Group. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2007-05-18.
- Submission: K070180
- Applicant / Sponsor: Respironics Inc., Sleep & Home Respiratory Group
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5700
- Decision date: 2007-05-18
Classification & Regulation
This clearance is catalogued under FDA product code LBI and 21 CFR 880.5700, within the General Hospital review panel as a Class II device.