Clearance Summary
UNI-VENT (R) MODEL 731 SERIES PORTABLE CRITICAL CARE VENTILATOR received FDA 510(k) clearance under submission number K111473, sponsored by Impact Instrumentation, 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 2012-02-16.
- Submission: K111473
- Applicant / Sponsor: Impact Instrumentation, Inc.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5895
- Decision date: 2012-02-16
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.