Clearance Summary
12 LEAD GLOVE received FDA 510(k) clearance under submission number K100315, sponsored by I Needmd, 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 2010-04-23.
- Submission: K100315
- Applicant / Sponsor: I Needmd, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2360
- Decision date: 2010-04-23
Classification & Regulation
This clearance is catalogued under FDA product code DRX and 21 CFR 870.2360, within the Cardiovascular review panel as a Class II device.