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510(k) K162768

Device
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
Applicant
INTEGRAL PROCESS SAS
510(k) number
K162768
Product code
DSA  
Decision
Substantially Equivalent (SESE)
Decision date
2017-08-16
Date received
2016-09-30
Regulation
870.2900
Classification name
Cable, Transducer And Electrode, Patient, (including Connector)
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Virginie S Grondin
Address
12 Rue Des Cayennes P.O. Box Bp 20310 Conflans Sainte Honorine FR 78703 78703

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
K252827IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559)Drägerwerk AG & Co. KGaA2025-12-01
K251669IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adapter cable, Draeger 7-pin, 2m; IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m; IBP transducer adapter cable, Baxter/Edwards, 0.3m; IBP transducer adapter cable, Baxter/Edwards, 2m; IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m; IBP transducer adapter cable, Draeger 10-pin, 0.3m; IBP transducer adapter cable, Draeger 7-pin, 0.3m; IBP transducer adapterShanghai Draeger Medical Instrument Co., Ltd.2025-09-30
K242986SpO2 Extension CableBeijing Rongrui-Century Science & Technology Co., Ltd.2025-05-02
K243545Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC; 989803170181, OR 5-Lead ECG Trunk Cable, AAMI/IEC; M1667A, 6 Lead ECG Trunk, AAMI/IEC 2.7m; M1668A,5 Lead ECG Trunk, AAMI/IEC 2.7m; M1669A,3 Lead ECG Trunk, AAMI/IEC 2.7m; M1949A,5+5 ECG Trunk cable AAMI, IEC 2.7m; M1663A,10 Lead ECG Trunk AAMI/IEC 2m; M1665A, 6+4 Lead ECG Trunk AAMI/IEC 2.7m; M1671A, 3 Leadset, Grabber, AAMI, ICU; M1673A, 3 Leadset, SnPhilips Medizin Systeme Böblingen GmbH2025-01-17
K240087RT Carbon ECG LeadsIvy Biomedical Systems, Inc.2024-09-13
K240377LIFEPAK® ECG CablesStryker Physio-Control2024-05-07
K240156LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021); LIFEPAK® Invasive Pressure Adapter Cable (interfaces with Edwards Lifesciences TruWave Invasive Pressure Transducers (or equivalent)) (11230-000024)Physio-Control, Inc.2024-04-30
K222712Fogg System Patient Monitoring CablesFogg System Company, Inc.2023-11-22
K230571RFP-100A Connector Cable (Single Use)Baylis Medical Technologies, Inc.2023-05-30
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
K211294Multi-Link X2 ECG Cable and Leadwire SystemVyaire Medical, Inc.2021-08-16
K203556Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient CablesMedtronic, Inc.2021-07-12

Legacy Summary#

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FDA Review#

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