Clearance Summary
BIRTHTRACK received FDA 510(k) clearance under submission number K080672, sponsored by Barnev, Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2008-07-08.
- Submission: K080672
- Applicant / Sponsor: Barnev, Ltd.
- Clearance pathway: Special
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 884.2800
- Decision date: 2008-07-08
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.