Clearance Summary
OB TRACEVUE OBSTETRICAL INFORMATION MANAGEMENT SYSTEM WITH RELEASE F.00 received FDA 510(k) clearance under submission number K081203, sponsored by Philips Medizin Systeme Boeblingen GmbH. 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 2008-05-28.
- Submission: K081203
- Applicant / Sponsor: Philips Medizin Systeme Boeblingen GmbH
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2740
- Decision date: 2008-05-28
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.