Clearance Summary
PRIMED TRACHEOSTOMY TUBES (MULTIPLE) received FDA 510(k) clearance under submission number K120079, sponsored by Primed Halberstadt Medizintechnik GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2012-05-24.
- Submission: K120079
- Applicant / Sponsor: Primed Halberstadt Medizintechnik GmbH
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5800
- Decision date: 2012-05-24
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.