Clearance Summary
BR-S601MU (SURGICAL VIDEO RECORDER) received FDA 510(k) clearance under submission number K890119, sponsored by Victor Co. of Japan, Ltd. C/O Jvc Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1989-01-24.
- Submission: K890119
- Applicant / Sponsor: Victor Co. of Japan, Ltd. C/O Jvc Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4160
- Decision date: 1989-01-24
Classification & Regulation
This clearance is catalogued under FDA product code FWC and 21 CFR 878.4160, within the General, Plastic Surgery review panel as a Class I device.