INSTRUMENT SCOPE

Endoscope, Neurological

CLARUS MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Clarus Medical Systems, Inc. with the FDA for Instrument Scope.

Pre-market Notification Details

Device IDK953685
510k NumberK953685
Device Name:INSTRUMENT SCOPE
ClassificationEndoscope, Neurological
Applicant CLARUS MEDICAL SYSTEMS, INC. 1000 BOONE AVENUE NORTH #100 Minneapolis,  MN  55427 -8656
ContactJohn Vanden Hoek
CorrespondentJohn Vanden Hoek
CLARUS MEDICAL SYSTEMS, INC. 1000 BOONE AVENUE NORTH #100 Minneapolis,  MN  55427 -8656
Product CodeGWG  
CFR Regulation Number882.1480 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-08-07
Decision Date1995-10-12

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.