Device Classification Name |
Oximeter
|
510(k) Number |
K040380 |
Device Name |
DOLPHIN MEDICAL DOLPHIN ONE ADULT REUSABLE FOREHEAD SENSOR, MODEL 420 |
Applicant |
DOLPHIN MEDICAL INC. |
14240 N. 42ND STREET |
APT 205 |
TAMPA,
FL
33613
|
|
Applicant Contact |
JON WERNER |
Correspondent |
DOLPHIN MEDICAL INC. |
14240 N. 42ND STREET |
APT 205 |
TAMPA,
FL
33613
|
|
Correspondent Contact |
JON WERNER |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 02/17/2004 |
Decision Date | 08/31/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|