The following data is part of a premarket notification filed by Us Jvc Corp. with the FDA for Ky-m280u Surgical Camera.
| Device ID | K854988 |
| 510k Number | K854988 |
| Device Name: | KY-M280U SURGICAL CAMERA |
| Classification | Camera, Television, Surgical, With Audio |
| Applicant | US JVC CORP. 41 SLATER DR. Elmwood Park, NJ 07407 |
| Contact | Ted Marks |
| Correspondent | Ted Marks US 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 | 1985-12-12 |
| Decision Date | 1986-01-24 |