Clearance Summary
Smart Peak Flow Meter received FDA 510(k) clearance under submission number K191239, sponsored by Guangzhou Homesun Medical Technology 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 2019-12-06.
- Submission: K191239
- Applicant / Sponsor: Guangzhou Homesun Medical Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1860
- Decision date: 2019-12-06
Classification & Regulation
This clearance is catalogued under FDA product code BZH and 21 CFR 868.1860, within the Anesthesiology review panel as a Class II device.