Clearance Summary
NEURO-ECAT received FDA 510(k) clearance under submission number K810589, sponsored by Eg&G Ortec, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1981-04-10.
- Submission: K810589
- Applicant / Sponsor: Eg&G Ortec, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1200
- Decision date: 1981-04-10
Classification & Regulation
This clearance is catalogued under FDA product code KPS and 21 CFR 892.1200, within the Radiology review panel as a Class II device.