Clearance Summary
InTouch Thermal Camera received FDA 510(k) clearance under submission number K181716, sponsored by Intouch Technologies, Inc., D.B.A. Intouch Health. 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 2019-03-25.
- Submission: K181716
- Applicant / Sponsor: Intouch Technologies, Inc., D.B.A. Intouch Health
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.2980
- Decision date: 2019-03-25
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.