Clearance Summary
COMPUTERIZED LABOR MONITORING SYSTEM received FDA 510(k) clearance under submission number DEN060006, sponsored by Barnev, Ltd.. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2007-01-30.
- Submission: DEN060006
- Applicant / Sponsor: Barnev, Ltd.
- Clearance pathway: Post-NSE
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 884.2800
- Decision date: 2007-01-30
Classification & Regulation
This clearance is catalogued under FDA product code NPB and 21 CFR 884.2800, within the Ophthalmic review panel as a Class II device.