Device Classification Name |
Ventilator, Continuous, Facility Use
|
510(k) Number |
K133868 |
Device Name |
ASTRAL VENTILATOR |
Applicant |
RESMED LTD. |
9001 SPECTRUM CENTER BLVD. |
SAN DIEGO,
CA
92123
|
|
Applicant Contact |
JIM CASSI |
Correspondent |
RESMED LTD. |
9001 SPECTRUM CENTER BLVD. |
SAN DIEGO,
CA
92123
|
|
Correspondent Contact |
JIM CASSI |
Regulation Number | 868.5895
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/20/2013 |
Decision Date | 06/04/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|