The following data is part of a premarket notification filed by Victor Co. Of Japan, Ltd. C/o Jvc Corp. with the FDA for Br-s601mu (surgical Video Recorder).
Device ID | K890119 |
510k Number | K890119 |
Device Name: | BR-S601MU (SURGICAL VIDEO RECORDER) |
Classification | Camera, Television, Surgical, With Audio |
Applicant | VICTOR CO. OF JAPAN, LTD. C/O JVC CORP. 41 SLATER DR. Elmwood Park, NJ 07407 |
Contact | Ted Marks |
Correspondent | Ted Marks VICTOR CO. OF JAPAN, LTD. C/O JVC CORP. 41 SLATER DR. Elmwood Park, NJ 07407 |
Product Code | FWC |
CFR Regulation Number | 878.4160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-01-11 |
Decision Date | 1989-01-24 |