Device Classification Name |
oximeter
|
510(k) Number |
K010463 |
Device Name |
DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSOIRES |
Applicant |
DATEX-OHMEDA, INC. |
3 HIGHWOOD DR. |
TEWKSBURY,
MA
01876
|
|
Applicant Contact |
JOEL C KENT |
Correspondent |
DATEX-OHMEDA, INC. |
3 HIGHWOOD DR. |
TEWKSBURY,
MA
01876
|
|
Correspondent Contact |
JOEL C KENT |
Regulation Number | 870.2700
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/16/2001 |
Decision Date | 03/15/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|