Clearance Summary
MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045 received FDA 510(k) clearance under submission number K050197, sponsored by Minitube of America, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2006-10-06.
- Submission: K050197
- Applicant / Sponsor: Minitube of America, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.6120
- Decision date: 2006-10-06
Classification & Regulation
This clearance is catalogued under FDA product code MQG and 21 CFR 884.6120, within the Obstetrics/Gynecology review panel as a Class II device.