Clearance Summary
PHOTOGRAPHIC EQUIPMENT received FDA 510(k) clearance under submission number K812201, sponsored by Reznik Instruments. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1981-10-19.
- Submission: K812201
- Applicant / Sponsor: Reznik Instruments
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.1500
- Decision date: 1981-10-19
Classification & Regulation
This clearance is catalogued under FDA product code FEM and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class I device.