PACHYCAM

Device, Analysis, Anterior Segment

OCULUS OPTIKGERATE GMBH

The following data is part of a premarket notification filed by Oculus Optikgerate Gmbh with the FDA for Pachycam.

Pre-market Notification Details

Device IDK041841
510k NumberK041841
Device Name:PACHYCAM
ClassificationDevice, Analysis, Anterior Segment
Applicant OCULUS OPTIKGERATE GMBH MUNCHHOLZHAUSER STRASSE 29 Wetzla-dutenhofen,  DE D-35582
ContactJoerg Iwanczuk
CorrespondentJoerg Iwanczuk
OCULUS OPTIKGERATE GMBH MUNCHHOLZHAUSER STRASSE 29 Wetzla-dutenhofen,  DE D-35582
Product CodeMXK  
CFR Regulation Number886.1850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-07-08
Decision Date2005-01-28
Summary:summary

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