Clearance Summary
LAMELLI OXYGEN ENRICHED ENVIRONMENT SYSTEM & TENT received FDA 510(k) clearance under submission number K884018, sponsored by Lamelli Pulmonary Research Center. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1989-02-27.
- Submission: K884018
- Applicant / Sponsor: Lamelli Pulmonary Research Center
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5440
- Decision date: 1989-02-27
Classification & Regulation
This clearance is catalogued under FDA product code CAW and 21 CFR 868.5440, within the Anesthesiology review panel as a Class II device.