Device Classification Name |
Filter, Bacterial, Breathing-Circuit
|
510(k) Number |
K964204 |
Device Name |
ENGSTROM HMEF 1000 |
Applicant |
DATEX ENGSTROM AB |
6329 W. WATERVIEW CT. |
MCCORDSVILLE,
IN
46055 -9501
|
|
Applicant Contact |
PAUL E DRYDEN |
Correspondent |
DATEX ENGSTROM AB |
6329 W. WATERVIEW CT. |
MCCORDSVILLE,
IN
46055 -9501
|
|
Correspondent Contact |
PAUL E DRYDEN |
Regulation Number | 868.5260 |
Classification Product Code |
|
Date Received | 08/29/1996 |
Decision Date | 11/13/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|