Device Classification Name |
ventilator, continuous, facility use
|
510(k) Number |
K980208 |
Device Name |
DIVAN ANESTHESIA VENTILATOR |
Applicant |
DRAEGER MEDICAL, INC. |
3135 QUARRY RD. |
TELFORD,
PA
18969
|
|
Applicant Contact |
JAMES J BRENNAN |
Correspondent |
DRAEGER MEDICAL, INC. |
3135 QUARRY RD. |
TELFORD,
PA
18969
|
|
Correspondent Contact |
JAMES J BRENNAN |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 01/20/1998 |
Decision Date | 08/04/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|