Clearance Summary
CLINICAL ALERT NOTIFICATION received FDA 510(k) clearance under submission number K130339, sponsored by Extension , Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2013-07-11.
- Submission: K130339
- Applicant / Sponsor: Extension , Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 2013-07-11
Classification & Regulation
This clearance is catalogued under FDA product code MSX and 21 CFR 870.2300, within the Cardiovascular review panel as a Class II device.