Clearance Summary
NAI TECH PRODUCTS MEDICAL DIGITAL RECORDER received FDA 510(k) clearance under submission number K042484, sponsored by Nai Technology Products. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2004-10-20.
- Submission: K042484
- Applicant / Sponsor: Nai Technology Products
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2030
- Decision date: 2004-10-20
Classification & Regulation
This clearance is catalogued under FDA product code LMA and 21 CFR 892.2030, within the Radiology review panel as a Class II device.