Clearance Summary
DELTEX MEDICAL CARDIOQ EDM received FDA 510(k) clearance under submission number K111542, sponsored by Deltex Medical Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2011-10-20.
- Submission: K111542
- Applicant / Sponsor: Deltex Medical Limited
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2100
- Decision date: 2011-10-20
Classification & Regulation
This clearance is catalogued under FDA product code DPW and 21 CFR 870.2100, within the Cardiovascular review panel as a Class II device.