FDA.reportPublic FDA data

510(k) K240377

Device
LIFEPAK® ECG Cables
Applicant
Stryker Physio-Control
510(k) number
K240377
Product code
DSA
Decision
Substantially Equivalent (SESE)
Decision date
2024-05-07
Date received
2024-02-07
Regulation
870.2900
Classification name
Cable, Transducer And Electrode, Patient, (Including Connector)
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Craig Schultz
Address
11811 Willows Rd. NE Redmond WA US 98052 98052

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DSA#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K254114Baylis Connector CableBaylis Medical Technologies, Inc.2026-01-18
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K240087RT Carbon ECG LeadsIvy Biomedical Systems, Inc.2024-09-13
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K222712Fogg System Patient Monitoring CablesFogg System Company, Inc.2023-11-22
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K222370SpO2 Extension CableBeijing Rongrui-Century Science & Technology Co., Ltd.2023-04-02
K220447Med-link Disposable ECG Cable and LeadwiresShenzhen Med-Link Electronics Tech Co., Ltd.2022-06-28
K2119419LineEnergetic Designs, Inc.2022-01-27
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K200722PCA-C1 series Patient CableQT Medical, Inc.2021-06-03