Clearance Summary
AlfaSight 9000 Thermographic System received FDA 510(k) clearance under submission number K150457, sponsored by Alfa Thermodiagnostics, 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 2015-04-10.
- Submission: K150457
- Applicant / Sponsor: Alfa Thermodiagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.2980
- Decision date: 2015-04-10
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.