Clearance Summary
OASIS received FDA 510(k) clearance under submission number K984218, sponsored by Glimex Corp.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1998-12-17.
- Submission: K984218
- Applicant / Sponsor: Glimex Corp.
- Clearance pathway: Abbreviated
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 1998-12-17
Classification & Regulation
This clearance is catalogued under FDA product code HIS and 21 CFR 884.5300, within the Obstetrics/Gynecology review panel as a Class II device.