Clearance Summary
EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01 received FDA 510(k) clearance under submission number K060289, sponsored by Frontline Medical. 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 2006-07-07.
- Submission: K060289
- Applicant / Sponsor: Frontline Medical
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2006-07-07
Classification & Regulation
This clearance is catalogued under FDA product code KNA and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.