Clearance Summary
Thermidas IR System (ThIR-A615) received FDA 510(k) clearance under submission number K200999, sponsored by Thermidas Americas, 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 2021-01-06.
- Submission: K200999
- Applicant / Sponsor: Thermidas Americas, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.2980
- Decision date: 2021-01-06
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.