Device Classification Name |
ventilator, continuous, non-life-supporting
|
510(k) Number |
K093731 |
Device Name |
VPAP III ST-A |
Applicant |
RESMED LTD. |
9001 SPECTRUM CENTER BLVD. |
SAN DIEGO,
CA
92123
|
|
Applicant Contact |
DAVID D'CURZ |
Correspondent |
RESMED LTD. |
9001 SPECTRUM CENTER BLVD. |
SAN DIEGO,
CA
92123
|
|
Correspondent Contact |
DAVID D'CURZ |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 12/03/2009 |
Decision Date | 03/22/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|