Clearance Summary
ECHOBRIGHT received FDA 510(k) clearance under submission number K111355, sponsored by Life-Tech, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2011-09-16.
- Submission: K111355
- Applicant / Sponsor: Life-Tech, Inc.
- Clearance pathway: Special
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5140
- Decision date: 2011-09-16
Classification & Regulation
This clearance is catalogued under FDA product code CAZ and 21 CFR 868.5140, within the Anesthesiology review panel as a Class II device.