Multi-Link X2 ECG and SpO2 Adapter
FDA 510(k) K191273 · Vyaire Medical, Inc.
510(k) numberK191273
Submission
- Device name
- Multi-Link X2 ECG and SpO2 Adapter
- Applicant
- Vyaire Medical, Inc.
Mettawa, IL, US - Received
- May 13, 2019
- Decision date
- September 13, 2019
- 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-Link X2 ECG and SpO2 Adapter cleared by the FDA?
Multi-Link X2 ECG and SpO2 Adapter (K191273) received a 510(k) decision of Substantially Equivalent on September 13, 2019, 123 days after the submission was received.
What is the product code of K191273?
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.