The following data is part of a premarket notification filed by Vyaire Medical, Inc. with the FDA for Multi-link X2 Ecg And Spo2 Adapter.
| Device ID | K191273 |
| 510k Number | K191273 |
| Device Name: | Multi-Link X2 ECG And SpO2 Adapter |
| Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
| Applicant | Vyaire Medical, Inc. 26125 N. Riverwoods Blvd. Mettawa, IL 60630 |
| Contact | Suzanne Moreno |
| Correspondent | Suzanne Moreno Vyaire Medical, Inc. 26125 N. Riverwoods Blvd. Mettawa, IL 60630 |
| Product Code | DSA |
| CFR Regulation Number | 870.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-13 |
| Decision Date | 2019-09-13 |
| Summary: | summary |