XENON LIGHT SOURCE

Light Source, Endoscope, Xenon Arc

ENVISION MEDICAL CORP.

The following data is part of a premarket notification filed by Envision Medical Corp. with the FDA for Xenon Light Source.

Pre-market Notification Details

Device IDK951971
510k NumberK951971
Device Name:XENON LIGHT SOURCE
ClassificationLight Source, Endoscope, Xenon Arc
Applicant ENVISION MEDICAL CORP. 749 WARD DR. Santa Barbara,  CA  93111
ContactDaniel P Mcguire
CorrespondentDaniel P Mcguire
ENVISION MEDICAL CORP. 749 WARD DR. Santa Barbara,  CA  93111
Product CodeGCT  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-04-27
Decision Date1995-05-24

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