The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corporation with the FDA for Logic 4k Camera Controller, Logic 4k Camera Head.
| Device ID | K180583 |
| 510k Number | K180583 |
| Device Name: | LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEAD |
| Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
| Applicant | Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, IL 60061 |
| Contact | Michael Loiterman |
| Correspondent | Michael Loiterman Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, IL 60061 |
| Product Code | FET |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-05 |
| Decision Date | 2018-06-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04055207063286 | K180583 | 000 |
| 04055207063163 | K180583 | 000 |