The following data is part of a premarket notification filed by Oculus Optikgerate Gmbh with the FDA for Pachycam.
| Device ID | K041841 |
| 510k Number | K041841 |
| Device Name: | PACHYCAM |
| Classification | Device, Analysis, Anterior Segment |
| Applicant | OCULUS OPTIKGERATE GMBH MUNCHHOLZHAUSER STRASSE 29 Wetzla-dutenhofen, DE D-35582 |
| Contact | Joerg Iwanczuk |
| Correspondent | Joerg Iwanczuk OCULUS OPTIKGERATE GMBH MUNCHHOLZHAUSER STRASSE 29 Wetzla-dutenhofen, DE D-35582 |
| Product Code | MXK |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-08 |
| Decision Date | 2005-01-28 |
| Summary: | summary |