Device Classification Name |
Vaporizer, Anesthesia, Non-Heated
|
510(k) Number |
K042276 |
Device Name |
D-VAPOR |
Applicant |
DRAEGER MEDICAL, INC. |
3135 QUARRY RD. |
TELFORD,
PA
18969
|
|
Applicant Contact |
GALE E WINARSKY |
Correspondent |
DRAEGER MEDICAL, INC. |
3135 QUARRY RD. |
TELFORD,
PA
18969
|
|
Correspondent Contact |
GALE E WINARSKY |
Regulation Number | 868.5880
|
Classification Product Code |
|
Date Received | 08/23/2004 |
Decision Date | 09/23/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|