Last synced on 30 September 2022 at 11:05 pm

SleepImage System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K182618
510(k) Type
Traditional
Applicant
MyCardio, LLC dba SleepImage.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/14/2019
Days to Decision
324 days
Submission Type
Summary

SleepImage System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K182618
510(k) Type
Traditional
Applicant
MyCardio, LLC dba SleepImage.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/14/2019
Days to Decision
324 days
Submission Type
Summary