CLARUS NEURO ENDOSCOPE (MODEL 2230)

Arthroscope

CLARUS MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Clarus Medical Systems, Inc. with the FDA for Clarus Neuro Endoscope (model 2230).

Pre-market Notification Details

Device IDK941188
510k NumberK941188
Device Name:CLARUS NEURO ENDOSCOPE (MODEL 2230)
ClassificationArthroscope
Applicant CLARUS MEDICAL SYSTEMS, INC. 1000 BOONE AVENUE NORTH #100 Minneapolis,  MN  55427 -8656
ContactJohn V Hoek
CorrespondentJohn V Hoek
CLARUS MEDICAL SYSTEMS, INC. 1000 BOONE AVENUE NORTH #100 Minneapolis,  MN  55427 -8656
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-03-14
Decision Date1995-04-25

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