Disposable Temporary Pacing Cable

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

TIGER MEDICAL PRODUCTS

The following data is part of a premarket notification filed by Tiger Medical Products with the FDA for Disposable Temporary Pacing Cable.

Pre-market Notification Details

Device IDK152947
510k NumberK152947
Device Name:Disposable Temporary Pacing Cable
ClassificationCable, Transducer And Electrode, Patient, (including Connector)
Applicant TIGER MEDICAL PRODUCTS JAJE PLAZA, SUITE 703, 1717 NORTH SICHUAN ROAD Shanghai,  CN 200080
ContactVeronica Lee
CorrespondentPamela Papineau
DELPHI MEDICAL DEVICE CONSULTING, INC 5 WHITCOMB AVENUE Ayer,  MA  01432
Product CodeDSA  
CFR Regulation Number870.2900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-10-06
Decision Date2016-04-05
Summary:summary

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