Clearance Summary
MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE received FDA 510(k) clearance under submission number K861845, sponsored by Directed Energy, 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 1986-08-11.
- Submission: K861845
- Applicant / Sponsor: Directed Energy, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4550
- Decision date: 1986-08-11
Classification & Regulation
This clearance is catalogued under FDA product code HHR and 21 CFR 884.4550, within the Obstetrics/Gynecology review panel as a Class II device.