CO2mbiLED

Insufflator, Automatic Carbon-dioxide For Endoscope

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 Co2mbiled.

Pre-market Notification Details

Device IDK201096
510k NumberK201096
Device Name:CO2mbiLED
ClassificationInsufflator, Automatic Carbon-dioxide For Endoscope
Applicant Karl Storz Endoscopy America, Inc. 2151 E. Grand Ave El Segundo,  CA  90245
ContactWinkie Wong
CorrespondentWinkie Wong
Karl Storz Endoscopy America, Inc. 2151 E. Grand Ave El Segundo,  CA  90245
Product CodeFCX  
Subsequent Product CodeFEQ
Subsequent Product CodeNTN
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-24
Decision Date2020-06-23

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