Clearance Summary
BSI MODEL MCT 7000-THERMAL IMAGING SYSTEM received FDA 510(k) clearance under submission number K850534, sponsored by Bales Scientific, 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 1985-02-27.
- Submission: K850534
- Applicant / Sponsor: Bales Scientific, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.2980
- Decision date: 1985-02-27
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.