Clearance Summary
MICROLIFE IT2CA1 received FDA 510(k) clearance under submission number K990168, sponsored by Microlife Systems AG. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1999-02-25.
- Submission: K990168
- Applicant / Sponsor: Microlife Systems AG
- Clearance pathway: Abbreviated
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 1999-02-25
Classification & Regulation
This clearance is catalogued under FDA product code FLL and 21 CFR 880.2910, within the General Hospital review panel as a Class II device.