Device Classification Name |
oximeter
|
510(k) Number |
K021955 |
Device Name |
TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES |
Applicant |
DATEX-OHMEDA, INC. |
1315 WEST CENTURY DR. |
LOUISVILLE,
CO
80027
|
|
Applicant Contact |
MICHAEL A CHILBERT |
Correspondent |
DATEX-OHMEDA, INC. |
1315 WEST CENTURY DR. |
LOUISVILLE,
CO
80027
|
|
Correspondent Contact |
MICHAEL A CHILBERT |
Regulation Number | 870.2700
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/14/2002 |
Decision Date | 10/08/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|