Clearance Summary
MEDEVICE V-80 VACUUM PUMP received FDA 510(k) clearance under submission number K840952, sponsored by Berkeley Medevices. 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 1984-03-30.
- Submission: K840952
- Applicant / Sponsor: Berkeley Medevices
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5070
- Decision date: 1984-03-30
Classification & Regulation
This clearance is catalogued under FDA product code HHI and 21 CFR 884.5070, within the Obstetrics/Gynecology review panel as a Class II device.