PULMODYNE CHF FLOW GENERATOR SYSTEM


Device Classification Name

attachment, breathing, positive end expiratory pressure

510(k) Number K080256
Device Name PULMODYNE CHF FLOW GENERATOR SYSTEM
Applicant
PULMODYNE
24301 woodsage drive
bonita springs, 
FL 
33134 -2958

Applicant Contact paul dryden
Correspondent
PULMODYNE
24301 woodsage drive
bonita springs, 
FL 
33134 -2958

Correspodent Contact paul dryden
Regulation Number 868.5965
Classification Product Code
BYE  
Date Received 01/31/2008
Decision Date 05/09/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No