Device Classification Name |
ventilator, continuous, facility use
|
510(k) Number |
K070899 |
Device Name |
PURITAN BENNETT LEGENDAIR XL2 |
Applicant |
NELLCOR PURITAN BENNETT |
4280 HACIENDA DR. |
PLEASANTON,
CA
94588
|
|
Applicant Contact |
JAMES BONDS |
Correspondent |
NELLCOR PURITAN BENNETT |
4280 HACIENDA DR. |
PLEASANTON,
CA
94588
|
|
Correspondent Contact |
JAMES BONDS |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 04/02/2007 |
Decision Date | 12/13/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|