NEGAVENT PLUS PEGASO COUGH, MODEL: DA-3 PLUS


Device Classification Name

device, positive pressure breathing, intermittent

510(k) Number K072292
Device Name NEGAVENT PLUS PEGASO COUGH, MODEL: DA-3 PLUS
Applicant
DIMA ITALIA SRL
4655 kirkwood ct.
boulder, 
CO 
80301

Applicant Contact lewis ward
Correspondent
DIMA ITALIA SRL
4655 kirkwood ct.
boulder, 
CO 
80301

Correspodent Contact lewis ward
Regulation Number 868.5905
Classification Product Code
NHJ  
Date Received 08/16/2007
Decision Date 01/07/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No