Clearance Summary
ORION PLUS/MODIFICATION received FDA 510(k) clearance under submission number K904840, sponsored by Mayer Laboratories. 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 1990-11-20.
- Submission: K904840
- Applicant / Sponsor: Mayer Laboratories
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 1990-11-20
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.