Clearance Summary
NU-SPEC D received FDA 510(k) clearance under submission number K012859, sponsored by Sol Weiss MD, Inc.. 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 2001-10-26.
- Submission: K012859
- Applicant / Sponsor: Sol Weiss MD, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2001-10-26
Classification & Regulation
This clearance is catalogued under FDA product code HIB and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.