Clearance Summary
CASS SYSTEM received FDA 510(k) clearance under submission number K894263, sponsored by Medical Instrumentation & Diagnostics Corp.(Midco). The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1989-09-01.
- Submission: K894263
- Applicant / Sponsor: Medical Instrumentation & Diagnostics Corp.(Midco)
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 1989-09-01
Classification & Regulation
This clearance is catalogued under FDA product code HAW and 21 CFR 882.4560, within the Neurology review panel as a Class II device.