Device Classification Name |
nebulizer (direct patient interface)
|
510(k) Number |
K990897 |
Device Name |
NELLCOR PURITAN BENNETT 700 SERIES VENTILATOR SYSTEM, AND EASYNEB NEBULIZER |
Applicant |
PURITAN-BENNETT IRELAND, LTD. |
MERVUE |
GALWAY,
IE
|
|
Applicant Contact |
ROBBIE WALSH |
Correspondent |
PURITAN-BENNETT IRELAND, LTD. |
MERVUE |
GALWAY,
IE
|
|
Correspondent Contact |
ROBBIE WALSH |
Regulation Number | 868.5630
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/18/1999 |
Decision Date | 03/15/2000 |
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
|
|
|