SureLead Cable System

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

Authentic Medical

The following data is part of a premarket notification filed by Authentic Medical with the FDA for Surelead Cable System.

Pre-market Notification Details

Device IDK181089
510k NumberK181089
Device Name:SureLead Cable System
ClassificationCable, Transducer And Electrode, Patient, (including Connector)
Applicant Authentic Medical 4470 Yankee Hill Rd., Ste 100 Rocklin,  CA  95677
ContactRicky Souza
CorrespondentRicky Souza
Authentic Medical 4470 Yankee Hill Rd., Ste 100 Rocklin,  CA  95677
Product CodeDSA  
CFR Regulation Number870.2900 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
510k Review PanelCardiovascular
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-04-25
Decision Date2020-01-17

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