Clearance Summary
GALAXY received FDA 510(k) clearance under submission number K061816, sponsored by Larsen & Toubro 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 2006-07-12.
- Submission: K061816
- Applicant / Sponsor: Larsen & Toubro Limited
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2300
- Decision date: 2006-07-12
Classification & Regulation
This clearance is catalogued under FDA product code MWI and 21 CFR 870.2300, within the Cardiovascular review panel as a Class II device.