Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K881648 |
Device Name |
TRANSFER CONTAINER HUMIDIFIER |
Applicant |
NEWPORT BIOSYSTEMS, INC. |
2480 MIDDLEFIELD RD. #2007 |
REDWOOD CITY,
CA
94063
|
|
Applicant Contact |
ROD ROBERTS |
Correspondent |
NEWPORT BIOSYSTEMS, INC. |
2480 MIDDLEFIELD RD. #2007 |
REDWOOD CITY,
CA
94063
|
|
Correspondent Contact |
ROD ROBERTS |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 04/15/1988 |
Decision Date | 12/30/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|