Clearance Summary
INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST received FDA 510(k) clearance under submission number K122480, sponsored by International Biophysics Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2013-03-27.
- Submission: K122480
- Applicant / Sponsor: International Biophysics Corporation
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5665
- Decision date: 2013-03-27
Classification & Regulation
This clearance is catalogued under FDA product code BYI and 21 CFR 868.5665, within the Anesthesiology review panel as a Class II device.