Clearance Summary
DOREX SPECTRUM 9000MB THERMOGRAPHY SYSTEM received FDA 510(k) clearance under submission number K023434, sponsored by Dorex, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2002-11-14.
- Submission: K023434
- Applicant / Sponsor: Dorex, Inc.
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.2980
- Decision date: 2002-11-14
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.