Multi-Link X2 ECG Cable and Lead Wire System
FDA 510(k) K162432 · Carefusion 2200, Inc.
510(k) numberK162432
Submission
- Device name
- Multi-Link X2 ECG Cable and Lead Wire System
- Applicant
- Carefusion 2200, Inc.
Vernon Hills, IL, US - Received
- August 31, 2016
- Decision date
- January 18, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DSA – Cable, Transducer And Electrode, Patient, (Including Connector)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2900
- Specialty
- Cardiovascular
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| K240156 | LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV…DSA · Traditional | Physio-Control, Inc. | 04/30/2024SE |
| K222712 | Fogg System Patient Monitoring CablesDSA · Traditional | Fogg System Company, Inc. | 11/22/2023SE |
| K230571 | RFP-100A Connector Cable (Single Use)DSA · Traditional | Baylis Medical Technologies, Inc. | 05/30/2023SE |
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Questions and answers
When was Multi-Link X2 ECG Cable and Lead Wire System cleared by the FDA?
Multi-Link X2 ECG Cable and Lead Wire System (K162432) received a 510(k) decision of Substantially Equivalent on January 18, 2017, 140 days after the submission was received.
What is the product code of K162432?
The FDA product code is DSA – Cable, Transducer And Electrode, Patient, (Including Connector), a Class II (moderate risk) device regulated under 21 CFR 870.2900.