FDA 510(k) Application Details - K240156

Device Classification Name Cable, Transducer And Electrode, Patient, (Including Connector)

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510(K) Number K240156
Device Name Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant Physio-Control, Inc.
11811 Willows Road NE
Redmond, WA 98052 US
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Contact Elisha McGaff
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Regulation Number 870.2900

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Classification Product Code DSA
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Date Received 01/19/2024
Decision Date 04/30/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K240156


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