Clearance Summary
DISPENSOR, XENON GAS received FDA 510(k) clearance under submission number K781933, sponsored by Diagnostic Isotapes, 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 1978-12-04.
- Submission: K781933
- Applicant / Sponsor: Diagnostic Isotapes, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1390
- Decision date: 1978-12-04
Classification & Regulation
This clearance is catalogued under FDA product code IYT and 21 CFR 892.1390, within the Radiology review panel as a Class II device.