FDA 510(k) Application Details - K240377

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

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510(K) Number K240377
Device Name Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant Stryker Physio-Control
11811 Willows Road NE
Redmond, WA 98052 US
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Contact Craig Schultz
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Regulation Number 870.2900

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Classification Product Code DSA
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Date Received 02/07/2024
Decision Date 05/07/2024
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 K240377


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