Clearance Summary
MODIFICATION TO HEALTH BUDDY WITH DEVICE CONNECTIVITY received FDA 510(k) clearance under submission number K042273, sponsored by Health Hero Network, 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 2004-08-31.
- Submission: K042273
- Applicant / Sponsor: Health Hero Network, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1130
- Decision date: 2004-08-31
Classification & Regulation
This clearance is catalogued under FDA product code DXN and 21 CFR 870.1130, within the Cardiovascular review panel as a Class II device.