Last synced on 20 May 2022 at 11:05 pm

Menai System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K160836
510(k) Type
Traditional
Applicant
ResMed Ltd
Country
Australia
FDA Decision
Substantially Equivalent
Decision Date
12/15/2016
Days to Decision
265 days
Submission Type
Summary

Menai System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K160836
510(k) Type
Traditional
Applicant
ResMed Ltd
Country
Australia
FDA Decision
Substantially Equivalent
Decision Date
12/15/2016
Days to Decision
265 days
Submission Type
Summary