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 |