Clearance Summary
BREASTVIEW VISUAL MAPPING SYSTEM received FDA 510(k) clearance under submission number DEN020001, sponsored by Assurance Medical. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2003-01-31.
- Submission: DEN020001
- Applicant / Sponsor: Assurance Medical
- Clearance pathway: Post-NSE
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2990
- Decision date: 2003-01-31
Classification & Regulation
This clearance is catalogued under FDA product code NKA and 21 CFR 884.2990, within the Obstetrics/Gynecology review panel as a Class II device.