Multi-Link X2 ECG Cable and Leadwire System— 510(k) K211294
Substantially EquivalentVyaire Medical, Inc.
FDA 510(k) clearance K211294 for Multi-Link X2 ECG Cable and Leadwire System, Substantially Equivalent on 2021-08-16. Applicant: Vyaire Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Vyaire Medical, Inc.
- Product code
- 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
- Mettawa, IL, US
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More clearances from Vyaire Medical, Inc.
view allAdverse 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.