Clearance Summary
ANT INFLATION DEVICE/ANT INFLATION DEVICE COMPACT PACK received FDA 510(k) clearance under submission number K102648, sponsored by Shenzhen Ant Hi-Tech Industrial Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2011-07-01.
- Submission: K102648
- Applicant / Sponsor: Shenzhen Ant Hi-Tech Industrial Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1650
- Decision date: 2011-07-01
Classification & Regulation
This clearance is catalogued under FDA product code MAV and 21 CFR 870.1650, within the Cardiovascular review panel as a Class II device.