Clearance Summary
HOTDOG PATIENT WARMING SYSTEM received FDA 510(k) clearance under submission number K112488, 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 2011-11-23.
- Submission: K112488
- Applicant / Sponsor: Augustine Biomedical & Design, LLC
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5900
- Decision date: 2011-11-23
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.