PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS


Device Classification Name

ventilator, external body, negative pressure, adult (cuirass)

510(k) Number K072290
Device Name PEGASO V, NEGAVENT RESPIRATOR, 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 868.5935
Classification Product Code
BYT  
Date Received 08/16/2007
Decision Date 05/29/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No