Clearance Summary
N 800 HF received FDA 510(k) clearance under submission number K953831, sponsored by Nucletron-Oldelft Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1995-09-08.
- Submission: K953831
- Applicant / Sponsor: Nucletron-Oldelft Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1700
- Decision date: 1995-09-08
Classification & Regulation
This clearance is catalogued under FDA product code IZO and 21 CFR 892.1700, within the Radiology review panel as a Class I device.