Clearance Summary
INFRAVIEW/INFRASION-TELETHERMOGRAPHIC SYSTEM received FDA 510(k) clearance under submission number K844771, sponsored by Image Systems, 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: K844771
- Applicant / Sponsor: Image Systems, 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.