Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K050072 |
Device Name |
GOODKNIGHT 425ST |
Applicant |
NELLCOR PURITAN BENNETT, INC. |
4280 HACIENDA DR. |
PLEASANTON,
CA
94588 -2719
|
|
Applicant Contact |
JAMES BONDS |
Correspondent |
NELLCOR PURITAN BENNETT, INC. |
4280 HACIENDA DR. |
PLEASANTON,
CA
94588 -2719
|
|
Correspondent Contact |
JAMES BONDS |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 01/12/2005 |
Decision Date | 06/13/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|