Clearance Summary
SKYTRON MODEL 860 AND 800 COMP. SURGITA NEURO EQUI received FDA 510(k) clearance under submission number K900472, sponsored by Skytron, Div. the Kmw Group, 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 1990-09-04.
- Submission: K900472
- Applicant / Sponsor: Skytron, Div. the Kmw Group, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class I
- Regulation citation: 21 CFR 882.4125
- Decision date: 1990-09-04
Classification & Regulation
This clearance is catalogued under FDA product code HBN and 21 CFR 882.4125, within the Neurology review panel as a Class I device.