Clearance Summary
PEAK EXPIRATORY FLOW METER, KN-9710 received FDA 510(k) clearance under submission number K092335, sponsored by K-Jump Health 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 2010-04-09.
- Submission: K092335
- Applicant / Sponsor: K-Jump Health Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1860
- Decision date: 2010-04-09
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.