Clearance Summary
BREATH SHAKE received FDA 510(k) clearance under submission number K121587, sponsored by Cheen Houng Ent. Co. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2013-11-22.
- Submission: K121587
- Applicant / Sponsor: Cheen Houng Ent. Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5665
- Decision date: 2013-11-22
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.