Clearance Summary
PEDIA-TRAKE CRICOTHYROTOMY KIT received FDA 510(k) clearance under submission number K840925, sponsored by Intl. Medical Devices , 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 1984-05-02.
- Submission: K840925
- Applicant / Sponsor: Intl. Medical Devices , Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5800
- Decision date: 1984-05-02
Classification & Regulation
This clearance is catalogued under FDA product code BTO and 21 CFR 868.5800, within the Anesthesiology review panel as a Class II device.