Clearance Summary
COMPUTER - COMPUTERS AND SOFTWARE, MEDICAL USE received FDA 510(k) clearance under submission number K923290, sponsored by A Mixed Bag Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1993-10-27.
- Submission: K923290
- Applicant / Sponsor: A Mixed Bag Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 1993-10-27
Classification & Regulation
This clearance is catalogued under FDA product code FRN and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.