Clearance Summary
MID-CANADA MEDICAL received FDA 510(k) clearance under submission number K922839, sponsored by Mid-Canada Medical. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1993-07-02.
- Submission: K922839
- Applicant / Sponsor: Mid-Canada Medical
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5300
- Decision date: 1993-07-02
Classification & Regulation
This clearance is catalogued under FDA product code IMI and 21 CFR 890.5300, within the Physical Medicine review panel as a Class II device.