OMNI~NEB; OMNI~MAX


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

Correspodent Contact stephen w briggs
Regulation Number 868.5630
Classification Product Code
CAF  
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