Clearance Summary
PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100 received FDA 510(k) clearance under submission number K034054, sponsored by Med-Tec,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 2004-02-20.
- Submission: K034054
- Applicant / Sponsor: Med-Tec,Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5770
- Decision date: 2004-02-20
Classification & Regulation
This clearance is catalogued under FDA product code JAI and 21 CFR 892.5770, within the Radiology review panel as a Class II device.