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510(k) K162768

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 by Integral Process Sas — Product Code DSA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2017
Date Received
September 30, 2016
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Device Class
Class II
Regulation Number
870.2900
Review Panel
CV
Submission Type

Other clearances by Integral Process Sas

  • K101685 — IP-SET (July 1, 2010)

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