MODIFICATION TO: EFLOW ELECTRONIC INHALER/NEBULIZER


Device Classification Name

nebulizer (direct patient interface)

510(k) Number K072670
Device Name MODIFICATION TO: EFLOW ELECTRONIC INHALER/NEBULIZER
Applicant
PARI INNOVATIVE MANUFACTURERS, INC.
2943 oaklake blvd.
midlothian, 
VA 
23112

Applicant Contact james mcintire
Regulation Number 868.5630
Classification Product Code
CAF  
Date Received 09/21/2007
Decision Date 12/13/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Special
Reviewed by Third Party Yes

Combination Product

Yes