Clearance Summary
MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM received FDA 510(k) clearance under submission number K912444, sponsored by Radiometer America, Inc.. 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 1992-02-18.
- Submission: K912444
- Applicant / Sponsor: Radiometer America, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5450
- Decision date: 1992-02-18
Classification & Regulation
This clearance is catalogued under FDA product code LGM and 21 CFR 880.5450, within the General Hospital review panel as a Class II device.