Clearance Summary
MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III) received FDA 510(k) clearance under submission number K970965, sponsored by Midas Rex Pneumatic Tools, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 1997-04-09.
- Submission: K970965
- Applicant / Sponsor: Midas Rex Pneumatic Tools, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.4250
- Decision date: 1997-04-09
Classification & Regulation
This clearance is catalogued under FDA product code ERL and 21 CFR 874.4250, within the Ear, Nose, Throat review panel as a Class II device.