Clearance Summary
MINI-MONITOR J7000 ICP received FDA 510(k) clearance under submission number K893395, sponsored by Ladd Research Industries, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1989-11-22.
- Submission: K893395
- Applicant / Sponsor: Ladd Research Industries, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1620
- Decision date: 1989-11-22
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.