Clearance Summary
DORNIR LC-1 CPAP SYSTEM received FDA 510(k) clearance under submission number K010704, sponsored by Prym Medical , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2001-04-18.
- Submission: K010704
- Applicant / Sponsor: Prym Medical , Ltd.
- Clearance pathway: Special
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5905
- Decision date: 2001-04-18
Classification & Regulation
This clearance is catalogued under FDA product code BZD and 21 CFR 868.5905, within the Anesthesiology review panel as a Class II device.