Clearance Summary
EXPOSET received FDA 510(k) clearance under submission number K922977, sponsored by S & S Inficon, 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 1992-11-27.
- Submission: K922977
- Applicant / Sponsor: S & S Inficon, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 1992-11-27
Classification & Regulation
This clearance is catalogued under FDA product code JAA and 21 CFR 892.1650, within the Radiology review panel as a Class II device.