Clearance Summary
REGUTHERM 952 THERMOGRAPHIC SYSTEM received FDA 510(k) clearance under submission number K003130, sponsored by Sie-Med, 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 2001-02-16.
- Submission: K003130
- Applicant / Sponsor: Sie-Med, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.2980
- Decision date: 2001-02-16
Classification & Regulation
This clearance is catalogued under FDA product code LHQ and 21 CFR 884.2980, within the Obstetrics/Gynecology review panel as a Class I device.