Clearance Summary
BREAST & BODY HEALTH SYSTEM 2000 received FDA 510(k) clearance under submission number K832731, sponsored by American Thermal Instruments, 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 1984-01-30.
- Submission: K832731
- Applicant / Sponsor: American Thermal Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class III
- Regulation citation: 21 CFR 884.2982
- Decision date: 1984-01-30
Classification & Regulation
This clearance is catalogued under FDA product code KXZ and 21 CFR 884.2982, within the Obstetrics/Gynecology review panel as a Class III device.