Clearance Summary
HOTDOG MULTI FUNCTION CONTROLLER received FDA 510(k) clearance under submission number K094056, sponsored by Augustine Biomedical & Design, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2010-06-03.
- Submission: K094056
- Applicant / Sponsor: Augustine Biomedical & Design, LLC
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5900
- Decision date: 2010-06-03
Classification & Regulation
This clearance is catalogued under FDA product code DWJ and 21 CFR 870.5900, within the Cardiovascular review panel as a Class II device.