Clearance Summary
PMP4 SPIROPRO received FDA 510(k) clearance under submission number K050853, sponsored by Card Guard Scientific Survival , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2005-05-04.
- Submission: K050853
- Applicant / Sponsor: Card Guard Scientific Survival , Ltd.
- Clearance pathway: Special
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1860
- Decision date: 2005-05-04
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.