Clearance Summary
SELDIX 325 TWO PULSE GENERATOR/CONTROL received FDA 510(k) clearance under submission number K883154, sponsored by Bay X-Ray, 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 1988-09-06.
- Submission: K883154
- Applicant / Sponsor: Bay X-Ray, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1700
- Decision date: 1988-09-06
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.