Device Classification Name |
vaporizer, anesthesia, non-heated
|
510(k) Number |
K971923 |
Device Name |
DRAGER-VAPOR 2000 |
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 | 868.5880
|
Classification Product Code |
|
Date Received | 05/23/1997 |
Decision Date | 09/16/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|