Clearance Summary
BIOVISION ENDOCULAR PROBE received FDA 510(k) clearance under submission number K905115, sponsored by Douglas James Donaldson Compliance Services. 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 1991-02-11.
- Submission: K905115
- Applicant / Sponsor: Douglas James Donaldson Compliance Services
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5070
- Decision date: 1991-02-11
Classification & Regulation
This clearance is catalogued under FDA product code HGF and 21 CFR 884.5070, within the Obstetrics/Gynecology review panel as a Class II device.