Clearance Summary
OB-1 FETAL MONITOR received FDA 510(k) clearance under submission number K011304, sponsored by Analogic Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2001-05-29.
- Submission: K011304
- Applicant / Sponsor: Analogic Corp.
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2740
- Decision date: 2001-05-29
Classification & Regulation
This clearance is catalogued under FDA product code HGM and 21 CFR 884.2740, within the Obstetrics/Gynecology review panel as a Class II device.