Clearance Summary
CRT2000 THERMOGRAPHIC SYSTEM received FDA 510(k) clearance under submission number K971956, sponsored by Werner Eidam Medizin-Technologie GmbH. 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 1997-08-22.
- Submission: K971956
- Applicant / Sponsor: Werner Eidam Medizin-Technologie GmbH
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.2980
- Decision date: 1997-08-22
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.