Medical Device Manufacturer · FI , Helsinki

Vyaire Medical, Inc. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2018

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Vyaire Medical, Inc. Cardiovascular ✕

3 devices

1-3 of 3

Cleared Aug 16, 2021

Multi-Link X2 ECG Cable and Leadwire System

Cardiovascular · 110d

Cleared Oct 09, 2020

Multi-LinkTM X2 ECG Adapter and Leadwires

Cardiovascular · 221d

Cleared Sep 13, 2019

Multi-Link X2 ECG and SpO2 Adapter

Cardiovascular · 123d