Clearance Summary
MODIFICATION TO TRUZONE PEAK FLOW METER received FDA 510(k) clearance under submission number K991212, sponsored by Monaghan Medical Corp.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1999-07-01.
- Submission: K991212
- Applicant / Sponsor: Monaghan Medical Corp.
- Clearance pathway: Abbreviated
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1860
- Decision date: 1999-07-01
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.