Clearance Summary
ICP MONITOR MODEL 1000 received FDA 510(k) clearance under submission number K844566, sponsored by Advanced Ultrasonic Testing & 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 1985-08-16.
- Submission: K844566
- Applicant / Sponsor: Advanced Ultrasonic Testing & Research Corp.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1620
- Decision date: 1985-08-16
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.