HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT)

Device, Analysis, Anterior Segment

HEIDELBERG ENGINEERING

The following data is part of a premarket notification filed by Heidelberg Engineering with the FDA for Heidelberg Engineering Slitlamp-oct (sl-oct).

Pre-market Notification Details

Device IDK052935
510k NumberK052935
Device Name:HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT)
ClassificationDevice, Analysis, Anterior Segment
Applicant HEIDELBERG ENGINEERING GERHART-HAUPTMANN-STRASSE 30 Dossenheim,  DE 69221
ContactGerhard Zinser
CorrespondentJeffrey D Rongero
UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle,  NC  27709
Product CodeMXK  
CFR Regulation Number886.1850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2005-10-19
Decision Date2006-01-13
Summary:summary

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