VIDEO BRONCHOSCOPE SYSTEM

Bronchoscope (flexible Or Rigid)

SCHOLLY FIBEROPTIC GMBH

The following data is part of a premarket notification filed by Scholly Fiberoptic Gmbh with the FDA for Video Bronchoscope System.

Pre-market Notification Details

Device IDK141366
510k NumberK141366
Device Name:VIDEO BRONCHOSCOPE SYSTEM
ClassificationBronchoscope (flexible Or Rigid)
Applicant SCHOLLY FIBEROPTIC GMBH ROBERT-BOSCH-STR. 1-3 Denzlingen,  DE D-79211
ContactSandra Baumann
CorrespondentSandra Baumann
SCHOLLY FIBEROPTIC GMBH ROBERT-BOSCH-STR. 1-3 Denzlingen,  DE D-79211
Product CodeEOQ  
CFR Regulation Number874.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-05-23
Decision Date2014-12-17
Summary:summary

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