Device Classification Name |
oximeter
|
510(k) Number |
K033876 |
Device Name |
DOLPHIN 2000 OXIMETRY SENSORS, MODELS 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342, 2343, 2344, 2220, 2260 AND 2422 |
Applicant |
DOLPHIN MEDICAL INC. |
9433 S. MORNING GLORY LN. |
LITTLETON,
CO
80130
|
|
Applicant Contact |
BILL CURNAN |
Correspondent |
DOLPHIN MEDICAL INC. |
9433 S. MORNING GLORY LN. |
LITTLETON,
CO
80130
|
|
Correspondent Contact |
BILL CURNAN |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 12/15/2003 |
Decision Date | 03/11/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|