Clearance Summary
GALAXY received FDA 510(k) clearance under submission number K083874, sponsored by Respironics Inc., Sleep & Home Respiratory Group. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2009-01-26.
- Submission: K083874
- Applicant / Sponsor: Respironics Inc., Sleep & Home Respiratory Group
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.2375
- Decision date: 2009-01-26
Classification & Regulation
This clearance is catalogued under FDA product code MNR and 21 CFR 868.2375, within the Anesthesiology review panel as a Class II device.