BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR

Insufflator, Automatic Carbon-dioxide For Endoscope

BRACCO DIAGNOSTIC, INC.

The following data is part of a premarket notification filed by Bracco Diagnostic, Inc. with the FDA for Bracco Diagnostics, Inc. Co2mpact Endodcopic Insufflator.

Pre-market Notification Details

Device IDK111648
510k NumberK111648
Device Name:BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR
ClassificationInsufflator, Automatic Carbon-dioxide For Endoscope
Applicant BRACCO DIAGNOSTIC, INC. 532 BROADHOLLOW ROAD SUITE 126 Melville,  NY  11747
ContactTracey Alexander
CorrespondentTracey Alexander
BRACCO DIAGNOSTIC, INC. 532 BROADHOLLOW ROAD SUITE 126 Melville,  NY  11747
Product CodeFCX  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-06-13
Decision Date2011-11-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10816765013103 K111648 000
00816765013182 K111648 000
00816765013175 K111648 000
00816765013168 K111648 000
10816765013110 K111648 000
10724995180383 K111648 000

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