The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Model Vy-800ra Optional Accessory To Bsm 8500a.
| Device ID | K883973 |
| 510k Number | K883973 |
| Device Name: | MODEL VY-800RA OPTIONAL ACCESSORY TO BSM 8500A |
| Classification | Display, Cathode-ray Tube, Medical |
| Applicant | NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine, CA 92714 |
| Contact | Mike Dashefsky |
| Correspondent | Mike Dashefsky NIHON KOHDEN AMERICA, INC. 17112 ARMSTRONG AVE. Irvine, CA 92714 |
| Product Code | DXJ |
| CFR Regulation Number | 870.2450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-20 |
| Decision Date | 1988-11-09 |