Device Classification Name |
ventilator, continuous, facility use
|
510(k) Number |
K051263 |
Device Name |
EVITAXL WITH OPTION SMARTCARE |
Applicant |
DRAGER MEDICAL AG & CO. KGAA |
3135 Quarry Road |
Telford,
PA
18969
|
|
Applicant Contact |
MONICA FERRANTE |
Correspondent |
DRAGER MEDICAL AG & CO. KGAA |
3135 Quarry Road |
Telford,
PA
18969
|
|
Correspondent Contact |
MONICA FERRANTE |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 05/16/2005 |
Decision Date | 07/12/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|