Clearance Summary
VERSALVENT MODEL V1 HYPERBARIC CHAMBER VENTILATOR MODEL V1 received FDA 510(k) clearance under submission number K122560, sponsored by Pan-America Hyperbarics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2013-03-26.
- Submission: K122560
- Applicant / Sponsor: Pan-America Hyperbarics, Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5895
- Decision date: 2013-03-26
Classification & Regulation
This clearance is catalogued under FDA product code CBK and 21 CFR 868.5895, within the Anesthesiology review panel as a Class II device.