The following data is part of a premarket notification filed by Leybold-inficon, Inc. with the FDA for Multi Camera Control Unit (mccu).
| Device ID | K884028 |
| 510k Number | K884028 |
| Device Name: | MULTI CAMERA CONTROL UNIT (MCCU) |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | LEYBOLD-INFICON, INC. 121 METROPOLOTON DR. Liverpool, NY 13088 |
| Contact | C Greenway |
| Correspondent | C Greenway LEYBOLD-INFICON, INC. 121 METROPOLOTON DR. Liverpool, NY 13088 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-23 |
| Decision Date | 1989-03-15 |