Clearance Summary
P-POD received FDA 510(k) clearance under submission number K133397, sponsored by P-Pod. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2014-04-18.
- Submission: K133397
- Applicant / Sponsor: P-Pod
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5970
- Decision date: 2014-04-18
Classification & Regulation
This clearance is catalogued under FDA product code MVA and 21 CFR 882.5970, within the Neurology review panel as a Class II device.