Device Classification Name |
ventilator, non-continuous (respirator)
|
510(k) Number |
K160836 |
Device Name |
Menai System |
Applicant |
ResMed Ltd |
1 Elizabeth Macarthur Drive |
Bella Vista,
AU
2153
|
|
Applicant Contact |
Greg Dockar |
Correspondent |
RESMED CORP |
9001 SPECTRUM CENTER BOULEVARD |
San Diego,
CA
92123
|
|
Correspondent Contact |
Larissa D’Andrea |
Regulation Number | 868.5905
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/25/2016 |
Decision Date | 12/15/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT02255539
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|