Clearance Summary
MEDONIC M SERIES received FDA 510(k) clearance under submission number K083420, sponsored by Boule Medical AB. The device was reviewed via the Special premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2009-02-03.
- Submission: K083420
- Applicant / Sponsor: Boule Medical AB
- Clearance pathway: Special
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5220
- Decision date: 2009-02-03
Classification & Regulation
This clearance is catalogued under FDA product code GKZ and 21 CFR 864.5220, within the Hematology review panel as a Class II device.