Clearance Summary
BREAST-SCAN(TM) received FDA 510(k) clearance under submission number K872962, sponsored by Thermascan, 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 1987-10-20.
- Submission: K872962
- Applicant / Sponsor: Thermascan, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.2982
- Decision date: 1987-10-20
Classification & Regulation
This clearance is catalogued under FDA product code LHM and 21 CFR 884.2982, within the Obstetrics/Gynecology review panel as a Class I device.