Clearance Summary
MICROLIFE ELECTRONIC PEAK FLOW MONITOR, WITH PEF AND FEV1, MODELS PF-100 AND PF-100-1 (WITH SOFTWARE) received FDA 510(k) clearance under submission number K040723, sponsored by Microlife Intellectual Property GmbH. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2004-06-10.
- Submission: K040723
- Applicant / Sponsor: Microlife Intellectual Property GmbH
- Clearance pathway: Abbreviated
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1860
- Decision date: 2004-06-10
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.