Clearance Summary
BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK received FDA 510(k) clearance under submission number K101130, sponsored by Respironics, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2010-09-02.
- Submission: K101130
- Applicant / Sponsor: Respironics, Inc.
- Clearance pathway: Special
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5895
- Decision date: 2010-09-02
Classification & Regulation
This clearance is catalogued under FDA product code MNS and 21 CFR 868.5895, within the Anesthesiology review panel as a Class II device.