Device Classification Name |
oximeter
|
510(k) Number |
K983684 |
Device Name |
DATEX-OHMEDA 3800+/3800P+ OR 3900/3900P PULSE OXIMETERS |
Applicant |
DATEX-OHMEDA, INC. |
1315 WEST CENTURY DR. |
LOUISVILLE,
CO
80027
|
|
Applicant Contact |
TOM KROENKE |
Correspondent |
DATEX-OHMEDA, INC. |
1315 WEST CENTURY DR. |
LOUISVILLE,
CO
80027
|
|
Correspondent Contact |
TOM KROENKE |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 10/20/1998 |
Decision Date | 11/06/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|