SONIK LDI 20 AIR


Device Classification Name

nebulizer (direct patient interface)

510(k) Number K030374
Device Name SONIK LDI 20 AIR
Applicant
EVIT LABS, INC.
4843 46th street, building 351
mcclellan, 
CA 
95652

Applicant Contact s. david piper
Correspondent
EVIT LABS, INC.
4843 46th street, building 351
mcclellan, 
CA 
95652

Correspodent Contact s. david piper
Regulation Number 868.5630
Classification Product Code
CAF  
Date Received 02/04/2003
Decision Date 08/25/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No