Clearance Summary
MASK, PXYGEN received FDA 510(k) clearance under submission number K781413, sponsored by Vitalab Products Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1978-09-07.
- Submission: K781413
- Applicant / Sponsor: Vitalab Products Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2120
- Decision date: 1978-09-07
Classification & Regulation
This clearance is catalogued under FDA product code DPT and 21 CFR 870.2120, within the Cardiovascular review panel as a Class II device.