Clearance Summary
INTRACRANIAL PRESSURING MONITORING SYST. received FDA 510(k) clearance under submission number K802100, sponsored by Pudenz-Schulte Medical Research Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1980-09-16.
- Submission: K802100
- Applicant / Sponsor: Pudenz-Schulte Medical Research Corp.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1620
- Decision date: 1980-09-16
Classification & Regulation
This clearance is catalogued under FDA product code GWM and 21 CFR 882.1620, within the Neurology review panel as a Class II device.