Clearance Summary
THERMO-5000 received FDA 510(k) clearance under submission number K895358, sponsored by Medtronix Ltd., 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 1990-05-07.
- Submission: K895358
- Applicant / Sponsor: Medtronix Ltd., Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.2980
- Decision date: 1990-05-07
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.