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
|
|
Correspondent Contact |
LEWIS WARD |
Regulation Number | 868.5935
|
Classification Product Code |
|
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
|
|
|