Clearance Summary
MODEL 90P PORTABLE MEDICAL DIAGNOSTIC X-RAY received FDA 510(k) clearance under submission number K934700, sponsored by Tempo Technology, 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 1994-03-16.
- Submission: K934700
- Applicant / Sponsor: Tempo Technology, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 1994-03-16
Classification & Regulation
This clearance is catalogued under FDA product code OXO and 21 CFR 892.1650, within the Radiology review panel as a Class II device.