Multi-Link X2 ECG Cable and Lead Wire System— 510(k) K162432
Substantially EquivalentCarefusion 2200, Inc.
FDA 510(k) clearance K162432 for Multi-Link X2 ECG Cable and Lead Wire System, Substantially Equivalent on 2017-01-18. Applicant: Carefusion 2200, Inc.. Device class: 2.
Clearance details
- Applicant
- Carefusion 2200, Inc.
- Product code
- Product code DSA
- Device class
- Class 2
- Regulation
- 21 CFR 870.2900
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Vernon Hills, IL, US
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Adverse events under product code DSA
product code DSA- Death
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.