Device Classification Name |
Cable, Transducer And Electrode, Patient, (Including Connector)
|
510(k) Number |
K191273 |
Device Name |
Multi-Link X2 ECG and SpO2 Adapter |
Applicant |
Vyaire Medical, Inc. |
26125 N. Riverwoods Blvd. |
Mettawa,
IL
60630
|
|
Applicant Contact |
Suzanne Moreno |
Correspondent |
Vyaire Medical, Inc. |
26125 N. Riverwoods Blvd. |
Mettawa,
IL
60630
|
|
Correspondent Contact |
Suzanne Moreno |
Regulation Number | 870.2900
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/13/2019 |
Decision Date | 09/13/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|