Device Classification Name |
condenser, heat and moisture (artificial nose)
|
510(k) Number |
K864095 |
Device Name |
ENGSTROM EDITH MODELS 500,1000,1500 & 1500F |
Applicant |
GAMBRO, INC. |
600 KNIGHTSBRIDGE PKWY. |
LINCOLNSHIRE,
IL
60069
|
|
Applicant Contact |
JEFFREY R SHIDEMAN |
Correspondent |
GAMBRO, INC. |
600 KNIGHTSBRIDGE PKWY. |
LINCOLNSHIRE,
IL
60069
|
|
Correspondent Contact |
JEFFREY R SHIDEMAN |
Regulation Number | 868.5375
|
Classification Product Code |
|
Date Received | 10/21/1986 |
Decision Date | 02/20/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|