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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 K240377
Device Name LIFEPAK® ECG Cables
Applicant
Stryker Physio-Control
11811 Willows Rd. NE
Redmond,  WA  98052
Applicant Contact Craig Schultz
Correspondent
Stryker Physio-Control
11811 Willows Rd. NE
Redmond,  WA  98052
Correspondent Contact Craig Schultz
Regulation Number870.2900
Classification Product Code
DSA  
Date Received02/07/2024
Decision Date 05/07/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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