Device Classification Name |
Ventilator, Continuous, Facility Use
|
510(k) Number |
K010793 |
Device Name |
OXYLOG 1000, MODEL 2M86840 |
Applicant |
DRAGER MEDIZINTECHNIK GMBH |
3135 QUARRY RD. |
TELFORD,
PA
18969
|
|
Applicant Contact |
JAMES J BRENNAN |
Correspondent |
DRAGER MEDIZINTECHNIK GMBH |
3135 QUARRY RD. |
TELFORD,
PA
18969
|
|
Correspondent Contact |
JAMES J BRENNAN |
Regulation Number | 868.5895
|
Classification Product Code |
|
Date Received | 03/16/2001 |
Decision Date | 12/20/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|