The following data is part of a premarket notification filed by Vyaire Medical, Inc. with the FDA for Multi-linktm X2 Ecg Adapter And Leadwires.
| Device ID | K200510 |
| 510k Number | K200510 |
| Device Name: | Multi-LinkTM X2 ECG Adapter And Leadwires |
| Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
| Applicant | Vyaire Medical, Inc. 26125 N. Riverwoods Blvd. Mettawa, IL 60045 |
| Contact | Suzanne Moreno |
| Correspondent | Suzanne Moreno Vyaire Medical, Inc. 26125 N. Riverwoods Blvd. Mettawa, IL 60045 |
| Product Code | DSA |
| CFR Regulation Number | 870.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-02 |
| Decision Date | 2020-10-09 |