The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corporation with the FDA for Logic Hd Camera Head Green, System Green.
| Device ID | K212808 |
| 510k Number | K212808 |
| Device Name: | Logic Hd Camera Head Green, System Green |
| 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 | 2021-09-03 |
| Decision Date | 2022-06-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04055207065617 | K212808 | 000 |