Clearance Summary
SPECTRUM DG-P7000 PEDIATRIC CRADLE received FDA 510(k) clearance under submission number K933134, sponsored by Spectrum X-Ray Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1993-10-07.
- Submission: K933134
- Applicant / Sponsor: Spectrum X-Ray Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1830
- Decision date: 1993-10-07
Classification & Regulation
This clearance is catalogued under FDA product code KXH and 21 CFR 892.1830, within the Radiology review panel as a Class I device.