Clearance Summary
O2PAK OXYGEN GENERATOR received FDA 510(k) clearance under submission number K120566, sponsored by Pacific Precision Products. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2012-07-24.
- Submission: K120566
- Applicant / Sponsor: Pacific Precision Products
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5440
- Decision date: 2012-07-24
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.