KARL STORZ ICG Imaging System

Confocal Optical Imaging

KARL STORZ Endoscopy_America, Inc.

The following data is part of a premarket notification filed by Karl Storz Endoscopy_america, Inc. with the FDA for Karl Storz Icg Imaging System.

Pre-market Notification Details

Device IDK202925
510k NumberK202925
Device Name:KARL STORZ ICG Imaging System
ClassificationConfocal Optical Imaging
Applicant KARL STORZ Endoscopy_America, Inc. 2151 E. Grand Avenue El Segundo,  CA  90245
ContactAlita Mcelroy
CorrespondentAlita Mcelroy
KARL STORZ Endoscopy_America, Inc. 2151 E. Grand Avenue El Segundo,  CA  90245
Product CodeOWN  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-29
Decision Date2020-12-17

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.