Device Classification Name |
Gas-Machine, Anesthesia
|
510(k) Number |
K033498 |
Device Name |
NARKOMED 6400, MODEL NM6400 |
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 | 868.5160
|
Classification Product Code |
|
Date Received | 11/05/2003 |
Decision Date | 04/26/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|