Last synced on 17 May 2024 at 11:06 pm

MRIaudio PREM System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180100
510(k) Type
Traditional
Applicant
MRIaudio
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/14/2018
Days to Decision
149 days
Submission Type
Summary