Clearance Summary
MORTARA STRESS ECHO BED received FDA 510(k) clearance under submission number K082967, sponsored by Medical Positioning, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2009-03-26.
- Submission: K082967
- Applicant / Sponsor: Medical Positioning, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2340
- Decision date: 2009-03-26
Classification & Regulation
This clearance is catalogued under FDA product code DPS and 21 CFR 870.2340, within the Cardiovascular review panel as a Class II device.