SleepImage System— 510(k) K182618
Substantially EquivalentMycardio, LLC Dba Sleepimage.
FDA 510(k) clearance K182618 for SleepImage System, Substantially Equivalent on 2019-08-14. Applicant: Mycardio, LLC Dba Sleepimage..
Clearance details
- Applicant
- Mycardio, LLC Dba Sleepimage.
- Product code
- Code MNR
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Denver, CO, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.