Device Classification Name |
Ventilator, Continuous, Non-Life-Supporting
|
510(k) Number |
K051364 |
Device Name |
VPAP ADAPT |
Applicant |
RESMED LTD. |
14040 DANIELSON ST. |
POWAY,
CA
92064 -6857
|
|
Applicant Contact |
DAVID D'CRUZ |
Correspondent |
RESMED LTD. |
14040 DANIELSON ST. |
POWAY,
CA
92064 -6857
|
|
Correspondent Contact |
DAVID D'CRUZ |
Regulation Number | 868.5895 |
Classification Product Code |
|
Date Received | 05/25/2005 |
Decision Date | 08/16/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|