Clearance Summary
Pylant Monitor received FDA 510(k) clearance under submission number K191858, sponsored by Kal-Med, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2020-02-24.
- Submission: K191858
- Applicant / Sponsor: Kal-Med, LLC
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5750
- Decision date: 2020-02-24
Classification & Regulation
This clearance is catalogued under FDA product code BSK and 21 CFR 868.5750, within the Anesthesiology review panel as a Class II device.