ENVIEW (TM)

Endoscope Holder

CAREFUSION 2200

The following data is part of a premarket notification filed by Carefusion 2200 with the FDA for Enview (tm).

Pre-market Notification Details

Device IDK102179
510k NumberK102179
Device Name:ENVIEW (TM)
ClassificationEndoscope Holder
Applicant CAREFUSION 2200 6215 FERRIS SQUARE, SUITE #100 San Diego,  CA  92121
ContactPatricia A Ayers
CorrespondentPatricia A Ayers
CAREFUSION 2200 6215 FERRIS SQUARE, SUITE #100 San Diego,  CA  92121
Product CodeOCV  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-08-03
Decision Date2010-12-02
Summary:summary

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