Clearance Summary
MEDI-STIM BUTTERFLY FLOWMETER, MODEL BF1000-BF2004 received FDA 510(k) clearance under submission number K992305, sponsored by Medi-Stim A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1999-09-08.
- Submission: K992305
- Applicant / Sponsor: Medi-Stim A/S
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1570
- Decision date: 1999-09-08
Classification & Regulation
This clearance is catalogued under FDA product code ITX and 21 CFR 892.1570, within the Radiology review panel as a Class II device.