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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cable, transducer and electrode, patient, (including connector)
510(k) Number K162768
Device Name ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables
Applicant
INTEGRAL PROCESS SAS
12 RUE DES CAYENNES
PO BOX BP 20310
CONFLANS SAINTE HONORINE,  FR 78703
Applicant Contact Virginie S Grondin
Correspondent
INTEGRAL PROCESS SAS
12 RUE DES CAYENNES
PO BOX BP 20310
CONFLANS SAINTE HONORINE,  FR 78703
Correspondent Contact Virginie S Grondin
Regulation Number870.2900
Classification Product Code
DSA  
Date Received09/30/2016
Decision Date 08/16/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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