Clearance Summary
ELECTRO-MYOGRAPHIC PERINEOMETER received FDA 510(k) clearance under submission number K854193, sponsored by Verimed Holdings, 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 1986-06-09.
- Submission: K854193
- Applicant / Sponsor: Verimed Holdings, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1425
- Decision date: 1986-06-09
Classification & Regulation
This clearance is catalogued under FDA product code HIR and 21 CFR 884.1425, within the Obstetrics/Gynecology review panel as a Class II device.