Clearance Summary
PLANET 55, MODEL 100 received FDA 510(k) clearance under submission number K090443, 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 2009-06-05.
- Submission: K090443
- Applicant / Sponsor: Larsen & Toubro Limited
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1025
- Decision date: 2009-06-05
Classification & Regulation
This clearance is catalogued under FDA product code MHX and 21 CFR 870.1025, within the Cardiovascular review panel as a Class II device.