Device Classification Name |
ventilator, emergency, manual (resuscitator)
|
510(k) Number |
K073410 |
Device Name |
SAVE RESUSCITATOR |
Applicant |
ARTIVENT CORPORATION |
3722 AVE. SAUSALITO |
IRVINE,
CA
92606
|
|
Applicant Contact |
GRACE HOLLAND |
Correspondent |
ARTIVENT CORPORATION |
3722 AVE. SAUSALITO |
IRVINE,
CA
92606
|
|
Correspondent Contact |
GRACE HOLLAND |
Regulation Number | 868.5915
|
Classification Product Code |
|
Date Received | 12/04/2007 |
Decision Date | 09/12/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|