Device Classification Name |
oximeter
|
510(k) Number |
K030952 |
Device Name |
DOLPHIN 2000 PULSE OXIMETRY SENSORS MODELS 2010, 2311 ADULT, 2312 PEDIATRIC, 2313 INFANT, 2314 NEONATAL, 2421 |
Applicant |
DOLPHIN MEDICAL INC. |
9433 S. MORNING GLORY LN. |
HIGHLANDS RANCH,
CO
80130
|
|
Applicant Contact |
BILL CURNAN |
Correspondent |
DOLPHIN MEDICAL INC. |
9433 S. MORNING GLORY LN. |
HIGHLANDS RANCH,
CO
80130
|
|
Correspondent Contact |
BILL CURNAN |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 03/26/2003 |
Decision Date | 05/19/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|