Curbell Branded Patient Monitoring Cables

Cable, Transducer And Electrode, Patient, (including Connector)

Curbell Medical Products, Inc.

The following data is part of a premarket notification filed by Curbell Medical Products, Inc. with the FDA for Curbell Branded Patient Monitoring Cables.

Pre-market Notification Details

Device IDK182220
510k NumberK182220
Device Name:Curbell Branded Patient Monitoring Cables
ClassificationCable, Transducer And Electrode, Patient, (including Connector)
Applicant Curbell Medical Products, Inc. 20 Centre Drive Orchard Park,  NY  14127
ContactMichael Winter
CorrespondentMichael Winter
Curbell Medical Products, Inc. 20 Centre Drive Orchard Park,  NY  14127
Product CodeDSA  
CFR Regulation Number870.2900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-08-15
Decision Date2018-11-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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