Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K030396 |
Device Name |
OMNI~NEB; OMNI~MAX |
Applicant |
B & B MEDICAL TECHNOLOGIES, INC. |
6731 32ND ST., SUITE A&B |
NORTH HIGHLANDS,
CA
95660
|
|
Applicant Contact |
STEPHEN W BRIGGS |
Correspondent |
B & B MEDICAL TECHNOLOGIES, INC. |
6731 32ND ST., SUITE A&B |
NORTH HIGHLANDS,
CA
95660
|
|
Correspondent Contact |
STEPHEN W BRIGGS |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 02/06/2003 |
Decision Date | 05/07/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|