DUET SYSTEM

Device, Automated Cell-locating

BIOVIEW LTD.

The following data is part of a premarket notification filed by Bioview Ltd. with the FDA for Duet System.

Pre-market Notification Details

Device IDK061602
510k NumberK061602
Device Name:DUET SYSTEM
ClassificationDevice, Automated Cell-locating
Applicant BIOVIEW LTD. 7 JABOTINSKY ST. Ramat Gan,  IL 52520
ContactDorit Winitz
CorrespondentDorit Winitz
BIOVIEW LTD. 7 JABOTINSKY ST. Ramat Gan,  IL 52520
Product CodeJOY  
CFR Regulation Number864.5260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-06-08
Decision Date2007-01-23
Summary:summary

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