PLEX Elite 9000 SS-OCT

Tomography, Optical Coherence

CARL ZEISS MEDITEC, INC.

The following data is part of a premarket notification filed by Carl Zeiss Meditec, Inc. with the FDA for Plex Elite 9000 Ss-oct.

Pre-market Notification Details

Device IDK161194
510k NumberK161194
Device Name:PLEX Elite 9000 SS-OCT
ClassificationTomography, Optical Coherence
Applicant CARL ZEISS MEDITEC, INC. 5160 HACIENDA DRIVE Dublin,  CA  94568
ContactChristine Dunbar
CorrespondentChristine Dunbar
CARL ZEISS MEDITEC, INC. 5160 HACIENDA DRIVE Dublin,  CA  94568
Product CodeOBO  
CFR Regulation Number886.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-04-27
Decision Date2016-10-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04057748087110 K161194 000

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