Medical Device Manufacturer · US , Broomfield , CO

Mycardio, LLC Dba Sleepimage. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2017

Recent clearances: SleepImage System, SleepImage System

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Mycardio, LLC Dba Sleepimage. Anesthesiology ✕

2 devices

1-2 of 2

Cleared Aug 14, 2019

SleepImage System

Anesthesiology · 324d

Cleared Oct 13, 2017

SleepImage System

Anesthesiology · 288d