PENTACAM SCHEIMPFLUG CAMERA

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 Pentacam Scheimpflug Camera.

Pre-market Notification Details

Device IDK030719
510k NumberK030719
Device Name:PENTACAM SCHEIMPFLUG CAMERA
ClassificationDevice, Analysis, Anterior Segment
Applicant OCULUS OPTIKGERATE GMBH 18902 NE 150TH ST. Woodinville,  WA  98072
ContactTom Weatherby
CorrespondentTom Weatherby
OCULUS OPTIKGERATE GMBH 18902 NE 150TH ST. Woodinville,  WA  98072
Product CodeMXK  
CFR Regulation Number886.1850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-03-07
Decision Date2003-09-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04049584000026 K030719 000
04049584000019 K030719 000

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