Clearance Summary
INFRAMETRICS INFRACAM-MED received FDA 510(k) clearance under submission number K982327, sponsored by Inframetrics, 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 1998-08-18.
- Submission: K982327
- Applicant / Sponsor: Inframetrics, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.2980
- Decision date: 1998-08-18
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.