Clearance Summary
RICA (DIAGNOSTIC INSTRUMENTS) received FDA 510(k) clearance under submission number K810054, sponsored by Robert I. Chien & Assoc., 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 1981-01-28.
- Submission: K810054
- Applicant / Sponsor: Robert I. Chien & Assoc., Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class I
- Regulation citation: 21 CFR 882.1700
- Decision date: 1981-01-28
Classification & Regulation
This clearance is catalogued under FDA product code GWZ and 21 CFR 882.1700, within the Neurology review panel as a Class I device.