Clearance Summary
AP201 DENTAL X-RAY FILM PROCESSOR received FDA 510(k) clearance under submission number K900156, sponsored by Allied Photo Products Co., 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 1990-05-14.
- Submission: K900156
- Applicant / Sponsor: Allied Photo Products Co., Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1900
- Decision date: 1990-05-14
Classification & Regulation
This clearance is catalogued under FDA product code EGY and 21 CFR 892.1900, within the Radiology review panel as a Class II device.