LIDCO CNAP MODULE

Computer, Diagnostic, Pre-programmed, Single-function

LIDCO LTD.

The following data is part of a premarket notification filed by Lidco Ltd. with the FDA for Lidco Cnap Module.

Pre-market Notification Details

Device IDK131048
510k NumberK131048
Device Name:LIDCO CNAP MODULE
ClassificationComputer, Diagnostic, Pre-programmed, Single-function
Applicant LIDCO LTD. 16 ORSMAN RD. London,  GB N15qj
ContactGregory Speller
CorrespondentGregory Speller
LIDCO LTD. 16 ORSMAN RD. London,  GB N15qj
Product CodeDXG  
CFR Regulation Number870.1435 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-04-15
Decision Date2013-08-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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05060110521005 K131048 000

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