Multi-LinkTM X2 ECG Adapter and Leadwires
FDA 510(k) K200510 · Vyaire Medical, Inc.
510(k) numberK200510
Submission
- Device name
- Multi-LinkTM X2 ECG Adapter and Leadwires
- Applicant
- Vyaire Medical, Inc.
Mettawa, IL, US - Received
- March 2, 2020
- Decision date
- October 9, 2020
- 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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Questions and answers
When was Multi-LinkTM X2 ECG Adapter and Leadwires cleared by the FDA?
Multi-LinkTM X2 ECG Adapter and Leadwires (K200510) received a 510(k) decision of Substantially Equivalent on October 9, 2020, 221 days after the submission was received.
What is the product code of K200510?
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.