Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K020357 |
Device Name |
800 SERIES EASYNEB NEBULIZER |
Applicant |
NELLCOR PURITAN BENNETT, INC. |
4280 HACIENDA DR. |
PLEASANTON,
CA
94588 -2719
|
|
Applicant Contact |
GINA TO |
Correspondent |
NELLCOR PURITAN BENNETT, INC. |
4280 HACIENDA DR. |
PLEASANTON,
CA
94588 -2719
|
|
Correspondent Contact |
GINA TO |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 02/04/2002 |
Decision Date | 08/07/2002 |
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
|
|
|