Clearance Summary
TECH DYNE - HP-2000, SKREEN TEST, RMS-200 received FDA 510(k) clearance under submission number K920183, sponsored by Tech Dyne Group. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1992-06-15.
- Submission: K920183
- Applicant / Sponsor: Tech Dyne Group
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.1240
- Decision date: 1992-06-15
Classification & Regulation
This clearance is catalogued under FDA product code LBB and 21 CFR 888.1240, within the Orthopedic review panel as a Class II device.