Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K913000 |
Device Name |
HEART NEBULIZER POLE CLAMP |
Applicant |
B & B MEDICAL TECHNOLOGIES, INC. |
P.O. BOX 1503 |
ORANGEVALE,
CA
95662
|
|
Applicant Contact |
STEPHEN W BRIGGS |
Correspondent |
B & B MEDICAL TECHNOLOGIES, INC. |
P.O. BOX 1503 |
ORANGEVALE,
CA
95662
|
|
Correspondent Contact |
STEPHEN W BRIGGS |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 07/08/1991 |
Decision Date | 08/02/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|