Device Classification Name |
Ventilator, Continuous, Facility Use
|
510(k) Number |
K063650 |
Device Name |
VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840 |
Applicant |
PURITAN BENNETT CORP. |
5391 PRIESTLY DR., SUITE 100 |
CARLSBAD,
CA
92008
|
|
Applicant Contact |
PATRICK GARVEY |
Correspondent |
PURITAN BENNETT CORP. |
5391 PRIESTLY DR., SUITE 100 |
CARLSBAD,
CA
92008
|
|
Correspondent Contact |
PATRICK GARVEY |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 12/08/2006 |
Decision Date | 02/15/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|